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).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Complete SE Vascular Stent System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Washington Hospital
  • Florida
    • Gainesville, Florida, United States, 32605
      • N. Florida Regional Medical Center
    • Ocala, Florida, United States, 34478
      • Munroe Regional Medical Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Event (MAE) Rate	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.	12 Months
Primary Patency Rate	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).	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Event (MAE) Rate	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.	30 days
Major Adverse Event (MAE) Rate	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.	6 Months
Device Success	The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.	At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Lesion Success	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.	At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Procedure Success	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.	At time of deployment to time of hospital discharge
Assisted Primary Patency	Defined as vessel patency resulting from a procedure performed in the treated segment.	12 months
Secondary Patency Rate	Defined as vessel patency resulting from any procedure that restores patency.	12 Months
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category	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).	12 months
Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15	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.	12 Months
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category	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).	30 Days
Percentage of Participants Free From Strut Fractures	Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.	12 Months
Clinically-driven Target Lesion Revascularization (TLR) Rate	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	12 Months
Major Adverse Event (MAE) Rate	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.	24 Months
Percentage of Participants Free From Strut Fractures	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.	24 Months
Major Adverse Event (MAE) Rate	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.	36 Months
Percentage of Participants Free From Strut Fractures	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.	36 Months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: John Laird, MD, University of California, Davis; Principal Investigator: Dierk Scheinert, PD, Park-Krankenhaus Leipzig-Sudost GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 23, 2008
• First Submitted That Met QC Criteria: December 24, 2008
• First Posted (ESTIMATE): December 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: PAD; stent; peripheral arterial disease; SFA; PPA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: IP105; IDE G080143 (OTHER: FDA)