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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00814970
First received: December 23, 2008
Last updated: October 9, 2014
Last verified: October 2014

December 23, 2008
October 9, 2014
November 2008
September 2011   (final data collection date for primary outcome measure)
  • Major Adverse Event (MAE) Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.
  • Primary Patency Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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).
MAE and Primary Patency Rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00814970 on ClinicalTrials.gov Archive Site
  • Major Adverse Event (MAE) Rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.
  • Major Adverse Event (MAE) Rate [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    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.
  • Device Success [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ] [ Designated as safety issue: Yes ]
    The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
  • Lesion Success [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ] [ Designated as safety issue: Yes ]
    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.
  • Procedure Success [ Time Frame: At time of deployment to time of hospital discharge ] [ Designated as safety issue: Yes ]
    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.
  • Assisted Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Defined as vessel patency resulting from a procedure performed in the treated segment.
  • Secondary Patency Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Defined as vessel patency resulting from any procedure that restores patency.
  • Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).
  • Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.
  • Change in Quality of Life - Decrease in Rutherford Class >= 1 Category [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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).
  • Percentage of Participants Free From Strut Fractures [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
  • Clinically-driven Target Lesion Revascularization (TLR) Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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
  • Major Adverse Event (MAE) Rate [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants Free From Strut Fractures [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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.
  • Major Adverse Event (MAE) Rate [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants Free From Strut Fractures [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    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.
  • MAE rate [ Time Frame: 30 days, 6 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]
  • Assisted primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Stent integrity [ Time Frame: 6, 12, 24, 36 Months ] [ Designated as safety issue: Yes ]
  • Acute success (device, lesion, procedure) [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
  • Change in quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries

To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Disease
Device: 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).
Experimental: Complete SE Vascular Stent System
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.
Intervention: Device: Complete SE Vascular Stent System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
December 2013
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
  2. Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur;
  3. Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
  4. Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
  5. Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
  6. Life expectancy >12 months.

    Exclusion Criteria:

  7. Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
  8. Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified;
  9. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
  10. Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion;
  11. Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
  12. Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure);
  13. History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
  14. Known impaired renal function, defined as creatinine >2.5 mg/dl;
  15. Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
  16. Known white blood cell (WBC) of <3,000 cells/mm3;
  17. Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814970
IP105, IDE G080143
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: John Laird, MD University of California, Davis
Principal Investigator: Dierk Scheinert, PD Park-Krankenhaus Leipzig-Sudost GmbH
Medtronic Endovascular
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP