Status:
COMPLETED
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 Popl...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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;
- Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
- Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
- Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel \<50% stenosed;
- Life expectancy \>12 months.
Exclusion
- Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
- 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;
- Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- 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;
- Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
- 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);
- History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
- Known impaired renal function, defined as creatinine \>2.5 mg/dl;
- Known platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3;
- Known white blood cell (WBC) of \<3,000 cells/mm3;
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00814970
Start Date
November 1 2008
End Date
December 1 2013
Last Update
April 13 2016
Active Locations (4)
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1
Washington Hospital
Fremont, California, United States, 94538
2
N. Florida Regional Medical Center
Gainesville, Florida, United States, 32605
3
Munroe Regional Medical Center
Ocala, Florida, United States, 34478
4
AnMed Health
Anderson, South Carolina, United States, 29621