Clinical trial NCT00814970: The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: PAD
peripheral arterial disease
stent
SFA
PPA
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Event (MAE) Rate
timeFrame: 12 Months
measure: Primary Patency Rate
timeFrame: 12 Months
Secondary outcomes:
measure: Major Adverse Event (MAE) Rate
timeFrame: 30 days
measure: Major Adverse Event (MAE) Rate
timeFrame: 6 Months
measure: Device Success
timeFrame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
measure: Lesion Success
timeFrame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
measure: Procedure Success
timeFrame: At time of deployment to time of hospital discharge
measure: Assisted Primary Patency
timeFrame: 12 months
measure: Secondary Patency Rate
timeFrame: 12 Months
measure: Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
timeFrame: 12 months
measure: Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
timeFrame: 12 Months
measure: Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
timeFrame: 30 Days
measure: Percentage of Participants Free From Strut Fractures
timeFrame: 12 Months
measure: Clinically-driven Target Lesion Revascularization (TLR) Rate
timeFrame: 12 Months
measure: Major Adverse Event (MAE) Rate
timeFrame: 24 Months
measure: Percentage of Participants Free From Strut Fractures
timeFrame: 24 Months
measure: Major Adverse Event (MAE) Rate
timeFrame: 36 Months
measure: Percentage of Participants Free From Strut Fractures
timeFrame: 36 Months
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Washington Hospital
state: California
city: Gainesville
country: United States
facility: N. Florida Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
Study officials:
affiliation: University of California, Davis
name: John Laird, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Park-Krankenhaus Leipzig-Sudost GmbH
name: Dierk Scheinert, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.