The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

• ClinicalTrials.gov Identifier: NCT00814970
• Recruitment Status: Completed
• First Posted: December 25, 2008
• Results First Posted: May 21, 2014
• Last Update Posted: April 13, 2016
• Sponsor: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Vascular Disease
• Intervention: Device: Complete SE Vascular Stent System
• Enrollment: 196

Participant Flow

Recruitment Details	Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.
Pre-assignment Details

Arm/Group Title	Complete Self-expanding (SE) Vascular Stent System
Arm/Group Description	Device: Complete Self-expanding (SE) Vascular Stent System > > Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Period Title: Overall Study
Started	196
Completed	146
Not Completed	50

Baseline Characteristics

Arm/Group Title		Complete SE Vascular Stent System
Arm/Group Description		Device: Complete SE Vascular Stent System> > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Baseline Participants		196
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	196 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	74 37.8%
	>=65 years	122 62.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	196 participants
		68.7 (10.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	196 participants
	Female	72 36.7%
	Male	124 63.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	196 participants
United States		133
Germany		48
Belgium		15

Outcome Measures

1. Primary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	11.0

2. Primary Outcome

Title	Primary Patency Rate
Description	Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	72.6

3. Secondary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	0.5

4. Secondary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	4.1

5. Secondary Outcome

Title	Device Success
Description	The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Time Frame	At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of lesions treated
	90.0

6. Secondary Outcome

Title	Lesion Success
Description	The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.
Time Frame	At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of lesions treated
	90.0

7. Secondary Outcome

Title	Procedure Success
Description	The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.
Time Frame	At time of deployment to time of hospital discharge

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of lesions treated
	89.1

8. Secondary Outcome

Title	Assisted Primary Patency
Description	Defined as vessel patency resulting from a procedure performed in the treated segment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	78.3

9. Secondary Outcome

Title	Secondary Patency Rate
Description	Defined as vessel patency resulting from any procedure that restores patency.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	78.9

10. Secondary Outcome

Title	Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
Description	Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	90.9

11. Secondary Outcome

Title	Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
Description	Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	64.5

12. Secondary Outcome

Title	Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
Description	Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	89.7

13. Secondary Outcome

Title	Percentage of Participants Free From Strut Fractures
Description	Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Overall Number of Units Analyzed; Type of Units Analyzed: Stents implanted with x-ray follow-up	189
Measure Type: Number; Unit of Measure: percentage of participants
	100.0

14. Secondary Outcome

Title	Clinically-driven Target Lesion Revascularization (TLR) Rate
Description	Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	Device: Complete SE Vascular Stent System > > Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	8.4

15. Secondary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation. Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	22.5

16. Secondary Outcome

Title	Percentage of Participants Free From Strut Fractures
Description	Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat (ITT)

Arm/Group Title	Complete Self-expanding (SE) Vascular Stent System
Arm/Group Description:	Device: Complete Self-expanding (SE) Vascular Stent System > > Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
Overall Number of Participants Analyzed	196
Overall Number of Units Analyzed; Type of Units Analyzed: Stents implanted with x-ray follow-up	159
Measure Type: Number; Unit of Measure: percentage of participants
	100.0

17. Secondary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation. Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
Overall Number of Participants Analyzed	196
Measure Type: Number; Unit of Measure: percentage of participants
	30.2

18. Secondary Outcome

Title	Percentage of Participants Free From Strut Fractures
Description	Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Complete SE Vascular Stent System
Arm/Group Description:	COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation. Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
Overall Number of Participants Analyzed	196
Overall Number of Units Analyzed; Type of Units Analyzed: Stents implanted with x-ray follow-up	159
Measure Type: Number; Unit of Measure: percentage of participants
	100.0

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	1. Complete SE Vascular Stent System
Arm/Group Description	Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
All-Cause Mortality
	1. Complete SE Vascular Stent System
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	1. Complete SE Vascular Stent System
	Affected / at Risk (%)	# Events
Total	117/196 (59.69%)
Blood and lymphatic system disorders
Anaemia † 1	8/196 (4.08%)	9
Thrombocytopenia † 1	1/196 (0.51%)	1
Cardiac disorders
Acute Myocardial Infarction † 1	4/196 (2.04%)	4
Angina Pectoris † 1	4/196 (2.04%)	4
Angina Unstable † 1	3/196 (1.53%)	3
Atrial Fibrillation † 1	4/196 (2.04%)	4
Atrioventricular Block † 1	1/196 (0.51%)	1
Bradycardia † 1	1/196 (0.51%)	1
Cardiac Failure † 1	3/196 (1.53%)	4
Cardiac Failure Congestive † 1	3/196 (1.53%)	4
Coronary Artery Disease † 1	10/196 (5.10%)	10
Myocardial Infarction † 1	2/196 (1.02%)	2
Myocardial Ischaemia † 1	1/196 (0.51%)	1
Sick Sinus Syndrome † 1	2/196 (1.02%)	2
Ventricular Tachycardia † 1	2/196 (1.02%)	2
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia † 1	1/196 (0.51%)	1
Eye disorders
Vitreous Haemorrhage † 1	1/196 (0.51%)	1
Gastrointestinal disorders
Abdominal Pain † 1	1/196 (0.51%)	1
Abdominal Strangulated Hernia † 1	1/196 (0.51%)	1
Ascites † 1	1/196 (0.51%)	1
Colitis † 1	1/196 (0.51%)	1
Duodenal Ulcer Perforation † 1	1/196 (0.51%)	1
Gastrointestinal Haemorrhage † 1	3/196 (1.53%)	3
Gastrooesophageal Reflux Disease † 1	1/196 (0.51%)	1
Mesenteric Vein Thrombosis † 1	1/196 (0.51%)	1
Pancreatitis Acute † 1	2/196 (1.02%)	2
Small Intestinal Obstruction † 1	2/196 (1.02%)	2
Vomiting † 1	1/196 (0.51%)	1
General disorders
Asthenia † 1	1/196 (0.51%)	2
Catheter Site Haemorrhage † 1	1/196 (0.51%)	1
Chest Pain † 1	9/196 (4.59%)	9
Gait Disturbance † 1	2/196 (1.02%)	2
Impaired Healing † 1	2/196 (1.02%)	2
Non-Cardiac Chest Pain † 1	1/196 (0.51%)	1
Pyrexia † 1	1/196 (0.51%)	1
Vessel Puncture Site Haematoma † 1	1/196 (0.51%)	1
Wound Necrosis † 1	1/196 (0.51%)	1
Hepatobiliary disorders
Bile Duct Stone † 1	1/196 (0.51%)	2
Gallbladder Disorder † 1	1/196 (0.51%)	1
Infections and infestations
Bronchitis † 1	4/196 (2.04%)	4
Bronchopneumonia † 1	1/196 (0.51%)	1
Cellulitis † 1	4/196 (2.04%)	5
Clostridium Difficile Colitis † 1	1/196 (0.51%)	1
Diverticulitis † 1	1/196 (0.51%)	1
Gangrene † 1	1/196 (0.51%)	1
Infection † 1	1/196 (0.51%)	1
Lobar Pneumonia † 1	1/196 (0.51%)	1
Localised Infection † 1	1/196 (0.51%)	1
Osteomyelitis † 1	1/196 (0.51%)	1
Osteomyelitis Acute † 1	1/196 (0.51%)	1
Pneumonia † 1	5/196 (2.55%)	5
Sepsis † 1	5/196 (2.55%)	5
Subcutaneous Abscess † 1	1/196 (0.51%)	1
Urinary Tract Infection † 1	2/196 (1.02%)	4
Wound Infection † 1	1/196 (0.51%)	1
Injury, poisoning and procedural complications
Device Electrical Finding † 1	1/196 (0.51%)	1
Hip Fracture † 1	1/196 (0.51%)	1
Humerus Fracture † 1	1/196 (0.51%)	1
In-Stent Arterial Restenosis † 1	14/196 (7.14%)	15
Pelvic Fracture † 1	1/196 (0.51%)	1
Stent Occlusion † 1	5/196 (2.55%)	5
Metabolism and nutrition disorders
Diabetes Mellitus † 1	1/196 (0.51%)	1
Failure To Thrive † 1	1/196 (0.51%)	1
Gout † 1	1/196 (0.51%)	1
Metabolic Acidosis † 1	1/196 (0.51%)	1
Musculoskeletal and connective tissue disorders
Back Pain † 1	2/196 (1.02%)	3
Pain In Extremity † 1	1/196 (0.51%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant † 1	1/196 (0.51%)	1
Malignant Melanoma † 1	1/196 (0.51%)	1
Neoplasm Malignant † 1	1/196 (0.51%)	1
Prostate Cancer † 1	1/196 (0.51%)	1
Nervous system disorders
Carotid Artery Stenosis † 1	7/196 (3.57%)	8
Cerebral Infarction † 1	1/196 (0.51%)	1
Cerebrovascular Accident † 1	2/196 (1.02%)	2
Dizziness † 1	1/196 (0.51%)	2
Hemiparesis † 1	1/196 (0.51%)	1
Presyncope † 1	1/196 (0.51%)	1
Spinal Claudication † 1	1/196 (0.51%)	1
Transient Ischaemic Attack † 1	1/196 (0.51%)	1
Psychiatric disorders
Alcohol Withdrawal Syndrome † 1	1/196 (0.51%)	1
Depression † 1	1/196 (0.51%)	1
Mental Status Changes † 1	2/196 (1.02%)	2
Psychotic Disorder † 1	1/196 (0.51%)	1
Renal and urinary disorders
Renal Artery Stenosis † 1	1/196 (0.51%)	1
Renal Failure Acute † 1	4/196 (2.04%)	4
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome † 1	1/196 (0.51%)	1
Acute Respiratory Failure † 1	1/196 (0.51%)	1
Chronic Obstructive Pulmonary Disease † 1	2/196 (1.02%)	2
Dyspnoea † 1	3/196 (1.53%)	3
Interstitial Lung Disease † 1	1/196 (0.51%)	1
Pleural Effusion † 1	1/196 (0.51%)	1
Pulmonary Embolism † 1	2/196 (1.02%)	2
Respiratory Failure † 1	1/196 (0.51%)	1
Skin and subcutaneous tissue disorders
Decubitus Ulcer † 1	1/196 (0.51%)	1
Skin Ulcer † 1	1/196 (0.51%)	1
Surgical and medical procedures
Hip Arthroplasty † 1	1/196 (0.51%)	1
Peripheral Revascularisation † 1	3/196 (1.53%)	3
Tendon Sheath Incision † 1	1/196 (0.51%)	1
Wound Debridement † 1	1/196 (0.51%)	1
Vascular disorders
Aneurysm † 1	1/196 (0.51%)	1
Arterial Occlusive Disease † 1	2/196 (1.02%)	2
Arterial Restenosis † 1	2/196 (1.02%)	2
Arterial Stenosis † 1	1/196 (0.51%)	3
Arterial Stenosis Limb † 1	5/196 (2.55%)	5
Artery Dissection † 1	7/196 (3.57%)	7
Femoral Arterial Stenosis † 1	16/196 (8.16%)	17
Femoral Artery Occlusion † 1	3/196 (1.53%)	3
Haematoma † 1	1/196 (0.51%)	1
Iliac Artery Stenosis † 1	1/196 (0.51%)	1
Intermittent Claudication † 1	13/196 (6.63%)	15
Peripheral Arterial Occlusive Disease † 1	2/196 (1.02%)	2
Peripheral Artery Dissection † 1	3/196 (1.53%)	3
Peripheral Embolism † 1	1/196 (0.51%)	1
Peripheral Ischaemia † 1	3/196 (1.53%)	3
Peripheral Vascular Disorder † 1	1/196 (0.51%)	1
Vascular Pseudoaneurysm † 1	1/196 (0.51%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 10.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	1. Complete SE Vascular Stent System
	Affected / at Risk (%)	# Events
Total	50/196 (25.51%)
General disorders
Chest Pain † 1	12/196 (6.12%)	13
Musculoskeletal and connective tissue disorders
Back Pain † 1	16/196 (8.16%)	16
Pain In Extremity † 1	15/196 (7.65%)	18
Vascular disorders
Intermittent Claudication † 1	17/196 (8.67%)	17
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 10.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Arslan Malik - Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular
• Phone: (707) 541-3256
• EMail: arslan.malik@medtronic.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00814970
• Other Study ID Numbers: IP105; IDE G080143 ( Other Identifier: FDA )
• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Results First Submitted: April 22, 2014
• Results First Posted: May 21, 2014
• Last Update Posted: April 13, 2016