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Trial record 2 of 25 for:    OSPREY

A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery (OSPREY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01118117
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : July 14, 2015
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Terumo Medical Corporation

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: Misago™ Self-Expanding Stent System
Enrollment 276
Recruitment Details  
Pre-assignment Details A total of 261 subjects were enrolled in the pivotal study cohort. An additional 15 subjects were implanted with a single, 150mm stent as part of a long length stent (LL) sub-study. The LL sub-study included safety data through 30 days post-procedure and was analyzed separately from the pivotal study cohort.
Arm/Group Title Misago™ Self-Expanding Stent System Long Length Stent Sub-Study Cohort
Hide Arm/Group Description Subjects received treatment with the Misago™ Self-Expanding Stent Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
Period Title: Overall Study
Started 261 15
Completed 240 15
Not Completed 21 0
Reason Not Completed
Death             8             0
Lost to Follow-up             6             0
Missed 12 Month Visit             7             0
Arm/Group Title Misago™ Self-Expanding Stent System Long Length (150mm) Misago™ Self-Expanding Stent System Total
Hide Arm/Group Description Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s) Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent Total of all reporting groups
Overall Number of Baseline Participants 261 15 276
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 15 participants 276 participants
69.3  (10) 70.7  (10.9) NA [1]   (NA)
[1]
Combined analysis of pivotal cohort and LL sub-study cohort was not completed
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 15 participants 276 participants
Female
92
  35.2%
8
  53.3%
100
  36.2%
Male
169
  64.8%
7
  46.7%
176
  63.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 261 participants 15 participants 276 participants
United States 201 15 216
Japan 50 0 50
Taiwan 9 0 9
Korea, Republic of 1 0 1
1.Primary Outcome
Title Primary Effectiveness Endpoint
Hide Description The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 261
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of stent patency
54.0
(48.0 to 60.0)
2.Primary Outcome
Title Primary Safety Endpoint
Hide Description The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.
Arm/Group Title Non-Randomized Long Length Stent Sub-Study Cohort
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Overall Number of Participants Analyzed 261 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects without a MAE
99.2
(97.1 to 100)
100
(92.8 to 100)
3.Secondary Outcome
Title Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort
Hide Description Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: percentage of stent patency
62.4
4.Secondary Outcome
Title Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort
Hide Description The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: percentage of stent patency
69.9
5.Secondary Outcome
Title Occurrence of Target Lesion Revascularization
Hide Description

The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.

Clinically driven defined as:

  • More than 50 percent stenosis with worsening symptoms, OR
  • More than 70 percent stenosis without symptoms
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 261
Measure Type: Number
Unit of Measure: percentage of subjects with TLR
13.0
6.Secondary Outcome
Title Device Related Peri-Procedural Complications
Hide Description Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)
Time Frame Prior to Hosptial Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants evaluated prior to hospital discharge
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 261
Measure Type: Number
Unit of Measure: percentage of subjects with event
2.3
7.Secondary Outcome
Title Technical Success
Hide Description

Technical Success defined by the following conditions:

  • Successful delivery of the stent at the lesion site
  • Stent(s) successfully deployed in lesion with adequate lesion coverage
Time Frame Intra-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled in pivotal trial
Arm/Group Title Non-Randomized Long Length Stent Sub-Study Cohort
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Overall Number of Participants Analyzed 261 15
Measure Type: Number
Unit of Measure: percentage of subjects with success
100 93.3
8.Secondary Outcome
Title Procedural Success
Hide Description Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
Time Frame Intra-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Randomized Long Length Stent Sub-Study Cohort
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Overall Number of Participants Analyzed 261 15
Measure Type: Number
Unit of Measure: percentage of subjects with success
93.5 100
9.Secondary Outcome
Title Clinical Success
Hide Description Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Randomized Long Length Stent Sub-Study Cohort
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Overall Number of Participants Analyzed 260 14
Measure Type: Number
Unit of Measure: percentage of subjects with success
90.0 92.9
10.Secondary Outcome
Title Major Adverse Events (MAEs) Through 12 Months Post-procedure
Hide Description The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 261
Measure Type: Number
Unit of Measure: percentage of subjects with event
16.1
11.Secondary Outcome
Title Stent Fracture at 12 Months
Hide Description Occurrence of stent fracture as determined by core laboratory analysis
Time Frame 12 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.
Arm/Group Title Non-Randomized
Hide Arm/Group Description:
Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Overall Number of Participants Analyzed 234
Overall Number of Units Analyzed
Type of Units Analyzed: Stents
324
Measure Type: Number
Unit of Measure: percentage of fracture occurrence
0.9
Time Frame For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-Randomized Long Length Stent Sub-study Cohort
Hide Arm/Group Description Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s) Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
All-Cause Mortality
Non-Randomized Long Length Stent Sub-study Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Non-Randomized Long Length Stent Sub-study Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   135/261 (51.72%)   1/15 (6.67%) 
Blood and lymphatic system disorders     
Anaemia  1  5/261 (1.92%)  0/15 (0.00%) 
Cardiac disorders     
Acute Coronary Syndrome  1  1/261 (0.38%)  0/15 (0.00%) 
Acute Myocardial Infarction  1  6/261 (2.30%)  0/15 (0.00%) 
Angina Pectoris  1  4/261 (1.53%)  0/15 (0.00%) 
Angina Unstable  1  2/261 (0.77%)  0/15 (0.00%) 
Atrial Fibrillation  1  3/261 (1.15%)  0/15 (0.00%) 
Cardiac Arrest  1  1/261 (0.38%)  0/15 (0.00%) 
Cardiac Failure Chronic  1  1/261 (0.38%)  0/15 (0.00%) 
Cardiac Failure Congestive  1  5/261 (1.92%)  0/15 (0.00%) 
Cardiogenic Shock  1  1/261 (0.38%)  0/15 (0.00%) 
Coronary Artery Disease  1  7/261 (2.68%)  0/15 (0.00%) 
Cyanosis  1  1/261 (0.38%)  0/15 (0.00%) 
Myocardial Infarction  1  1/261 (0.38%)  0/15 (0.00%) 
Pericarditis Constrictive  1  1/261 (0.38%)  0/15 (0.00%) 
Ventricular Extrasystoles  1  1/261 (0.38%)  0/15 (0.00%) 
Ventricular Fibrillation  1  1/261 (0.38%)  0/15 (0.00%) 
Eye disorders     
Amaurosis Fugax  1  1/261 (0.38%)  0/15 (0.00%) 
Cataract  1  2/261 (0.77%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  1/261 (0.38%)  0/15 (0.00%) 
Colitis  1  1/261 (0.38%)  0/15 (0.00%) 
Diverticulum  1  1/261 (0.38%)  0/15 (0.00%) 
Enteritis  1  1/261 (0.38%)  0/15 (0.00%) 
Gastric Ulcer  1  1/261 (0.38%)  0/15 (0.00%) 
Gastrointestinal haemorrhage  1  4/261 (1.53%)  0/15 (0.00%) 
Hiatus Hernia  1  1/261 (0.38%)  0/15 (0.00%) 
Impaired Gastric emptying  1  1/261 (0.38%)  0/15 (0.00%) 
Intestinal ischaemia  1  1/261 (0.38%)  0/15 (0.00%) 
Mesenteric Artery S'tenosis  1  1/261 (0.38%)  0/15 (0.00%) 
Pancreatitis Acute  1  1/261 (0.38%)  0/15 (0.00%) 
Periodontitis  1  1/261 (0.38%)  0/15 (0.00%) 
Retroperitoneal haemorrhage  1  1/261 (0.38%)  0/15 (0.00%) 
Small Intestinal Obstruction  1  1/261 (0.38%)  0/15 (0.00%) 
General disorders     
Asthenia  1  2/261 (0.77%)  0/15 (0.00%) 
Chest Pain  1  1/261 (0.38%)  0/15 (0.00%) 
Death  1  1/261 (0.38%)  0/15 (0.00%) 
Device Failure  1  1/261 (0.38%)  0/15 (0.00%) 
Device Occllusion  1  3/261 (1.15%)  0/15 (0.00%) 
Generalised Oedema  1  1/261 (0.38%)  0/15 (0.00%) 
Malaise  1  1/261 (0.38%)  0/15 (0.00%) 
Non-Cardiac Chest Pain  1  1/261 (0.38%)  0/15 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/261 (0.38%)  0/15 (0.00%) 
Cholecystitis Acute  1  1/261 (0.38%)  0/15 (0.00%) 
Hyperbilirubinaemia  1  1/261 (0.38%)  0/15 (0.00%) 
Infections and infestations     
Appendicitis  1  1/261 (0.38%)  0/15 (0.00%) 
Appendicitis Perforated  1  1/261 (0.38%)  0/15 (0.00%) 
Bronchitis  1  1/261 (0.38%)  0/15 (0.00%) 
Cellulitis  1  4/261 (1.53%)  0/15 (0.00%) 
Cholecystitis Infective  1  1/261 (0.38%)  0/15 (0.00%) 
Diverticulitis  1  1/261 (0.38%)  0/15 (0.00%) 
Gangrene  1  1/261 (0.38%)  0/15 (0.00%) 
Gastroenteritis  1  1/261 (0.38%)  0/15 (0.00%) 
Graft Infection  1  1/261 (0.38%)  0/15 (0.00%) 
Nasopharyngitis  1  1/261 (0.38%)  0/15 (0.00%) 
Osteomyelitis  1  1/261 (0.38%)  0/15 (0.00%) 
Pneumonia  1  6/261 (2.30%)  0/15 (0.00%) 
Post-Operative Wound Infection  1  1/261 (0.38%)  0/15 (0.00%) 
Sepsis  1  2/261 (0.77%)  0/15 (0.00%) 
Septic Shock  1  2/261 (0.77%)  0/15 (0.00%) 
Urinary Tract Infection  1  2/261 (0.77%)  0/15 (0.00%) 
Wound Infection  1  1/261 (0.38%)  0/15 (0.00%) 
Injury, poisoning and procedural complications     
Arterial Restenosis  1  4/261 (1.53%)  0/15 (0.00%) 
Coronary Artery Restenosis  1  1/261 (0.38%)  0/15 (0.00%) 
Femoral Neck Fracture  1  1/261 (0.38%)  0/15 (0.00%) 
Hip Fracture  1  1/261 (0.38%)  0/15 (0.00%) 
Peripheral Artery Restenosis  1  30/261 (11.49%)  0/15 (0.00%) 
Renal Haematoma  1  1/261 (0.38%)  0/15 (0.00%) 
Toxicity to Various Agents  1  1/261 (0.38%)  0/15 (0.00%) 
Vascular Pseudoaneurysm  1  2/261 (0.77%)  0/15 (0.00%) 
Wrist Fracture  1  1/261 (0.38%)  0/15 (0.00%) 
Investigations     
Pulse Absent  1  1/261 (0.38%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  1/261 (0.38%)  0/15 (0.00%) 
Dehydration  1  1/261 (0.38%)  0/15 (0.00%) 
Hyperglycaemia  1  1/261 (0.38%)  0/15 (0.00%) 
Hypoglycaemia  1  1/261 (0.38%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/261 (0.38%)  0/15 (0.00%) 
Osteoarthritis  1  2/261 (0.77%)  0/15 (0.00%) 
Pain in Extremity  1  4/261 (1.53%)  0/15 (0.00%) 
Spondylolisthesis  1  1/261 (0.38%)  0/15 (0.00%) 
Right Lower Extremity Pain * 1  0/261 (0.00%)  1/15 (6.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign Pancreatic Neoplasm  1  1/261 (0.38%)  0/15 (0.00%) 
Bladder Neoplasm  1  1/261 (0.38%)  0/15 (0.00%) 
Hepatic Neoplasm Malignant  1  2/261 (0.77%)  0/15 (0.00%) 
Lung Adenocarcinoma  1  1/261 (0.38%)  0/15 (0.00%) 
Lung Neoplasm Malignant  1  1/261 (0.38%)  0/15 (0.00%) 
Nervous system disorders     
Balance Disorder  1  1/261 (0.38%)  0/15 (0.00%) 
Brain stem Stroke  1  1/261 (0.38%)  0/15 (0.00%) 
Carotid Artery Stenosis  1  3/261 (1.15%)  0/15 (0.00%) 
Carotic Artery Disease  1  2/261 (0.77%)  0/15 (0.00%) 
Cerbral haemorrhage  1  1/261 (0.38%)  0/15 (0.00%) 
Cerbral Infarction  1  1/261 (0.38%)  0/15 (0.00%) 
Convulsion  1  1/261 (0.38%)  0/15 (0.00%) 
Dizziness  1  2/261 (0.77%)  0/15 (0.00%) 
Cerebrovascular Accident  1  3/261 (1.15%)  0/15 (0.00%) 
Essential Tremor  1  1/261 (0.38%)  0/15 (0.00%) 
Lacunar Infarction  1  1/261 (0.38%)  0/15 (0.00%) 
Metabolic Encephalopathy  1  1/261 (0.38%)  0/15 (0.00%) 
Sciatica  1  1/261 (0.38%)  0/15 (0.00%) 
Spondylitic myelopathy  1  1/261 (0.38%)  0/15 (0.00%) 
Syncope  1  1/261 (0.38%)  0/15 (0.00%) 
Transient Ischaemic Attack  1  1/261 (0.38%)  0/15 (0.00%) 
Psychiatric disorders     
Mental Status Changes  1  2/261 (0.77%)  0/15 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/261 (0.38%)  0/15 (0.00%) 
Renal Artery Stenosis  1  1/261 (0.38%)  0/15 (0.00%) 
Renal Failure Acute  1  7/261 (2.68%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  1/261 (0.38%)  0/15 (0.00%) 
Chronic Obstructive Pulmonary Disease  1  3/261 (1.15%)  0/15 (0.00%) 
Dyspnoea  1  1/261 (0.38%)  0/15 (0.00%) 
Pneumonia Aspiration  1  1/261 (0.38%)  0/15 (0.00%) 
Pneumonitis  1  1/261 (0.38%)  0/15 (0.00%) 
Pneumothorax  1  1/261 (0.38%)  0/15 (0.00%) 
Pulmonary Hypertension  1  1/261 (0.38%)  0/15 (0.00%) 
Pulmonary Oedema  1  1/261 (0.38%)  0/15 (0.00%) 
Respiratory Failure  1  2/261 (0.77%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Ulcer  1  1/261 (0.38%)  0/15 (0.00%) 
Vascular disorders     
Arterial Thrombosis  1  1/261 (0.38%)  0/15 (0.00%) 
Arteriosclerosis  1  1/261 (0.38%)  0/15 (0.00%) 
Extremity Necrosis  1  1/261 (0.38%)  0/15 (0.00%) 
Femoral Artery Dissection  1  1/261 (0.38%)  0/15 (0.00%) 
Femoral Artery Occlusion  1  4/261 (1.53%)  0/15 (0.00%) 
Haematoma  1  1/261 (0.38%)  0/15 (0.00%) 
Hypertension  1  4/261 (1.53%)  0/15 (0.00%) 
Hypertensive Emergency  1  1/261 (0.38%)  0/15 (0.00%) 
Hypotension  1  4/261 (1.53%)  0/15 (0.00%) 
Iliac Artery Occlusion  1  2/261 (0.77%)  0/15 (0.00%) 
Intermittent Claudication  1  15/261 (5.75%)  0/15 (0.00%) 
Ischaemic Limb Pain  1  1/261 (0.38%)  0/15 (0.00%) 
Peripheral Artercy Occlusive Disease  1  2/261 (0.77%)  0/15 (0.00%) 
Peripheral Artery Stenosis  1  11/261 (4.21%)  0/15 (0.00%) 
Peripheral Embolism  1  1/261 (0.38%)  0/15 (0.00%) 
Peripheral Ischaemia  1  1/261 (0.38%)  0/15 (0.00%) 
Peripheral Vascular Disorder  1  5/261 (1.92%)  0/15 (0.00%) 
Subclavian Artery stenosis  1  1/261 (0.38%)  0/15 (0.00%) 
Vascular Pseudoaneurysm  1  1/261 (0.38%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-Randomized Long Length Stent Sub-study Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   167/261 (63.98%)   7/15 (46.67%) 
Blood and lymphatic system disorders     
Anaemia  1  13/261 (4.98%)  0/15 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  0/261 (0.00%)  1/15 (6.67%) 
General disorders     
Non-Cardiac Chest Pain * 1  0/261 (0.00%)  1/15 (6.67%) 
Immune system disorders     
Allergy to Vancomycin * 1  0/261 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Peripheral Artery Restenosis  1  41/261 (15.71%)  0/15 (0.00%) 
hypertension post-procedure * 1  0/261 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  21/261 (8.05%)  0/15 (0.00%) 
Pain in Exteremity  1  14/261 (5.36%)  0/15 (0.00%) 
bilateral leg cramps * 1  0/261 (0.00%)  1/15 (6.67%) 
Nervous system disorders     
Burning Right Leg * 1  0/261 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Renal Artery Stenosis * 1  0/261 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Rash-waist to knees * 1  0/261 (0.00%)  1/15 (6.67%) 
Vascular disorders     
Haematoma  1  13/261 (4.98%)  0/15 (0.00%) 
Hypertension  1  22/261 (8.43%)  0/15 (0.00%) 
Intermittent Claudication  1  27/261 (10.34%)  0/15 (0.00%) 
Peripheral Artery Stenosis  1  16/261 (6.13%)  0/15 (0.00%) 
Post Dilatation Dissection * 1  0/261 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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
Layout table for Results Point of Contact information
Name/Title: Adam Thompson, Clinical Program Manager
Organization: Terumo Medical Corporation
Phone: 201-398-3283
EMail: adam.thompson@terumomedical.com
Layout table for additonal information
Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT01118117    
Other Study ID Numbers: TIS2009-02
First Submitted: May 4, 2010
First Posted: May 6, 2010
Results First Submitted: June 18, 2015
Results First Posted: July 14, 2015
Last Update Posted: November 20, 2017