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The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions | Clinical Trials | Clareo Health

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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

NCT00814970•Medtronic Endovascular

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (4)

Washington Hospital

Fremont, California, United States

N. Florida Regional Medical Center

Gainesville, Florida, United States

Munroe Regional Medical Center

Ocala, Florida, United States

AnMed Health

Anderson, South Carolina, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

September 1, 2011

Completion Date

December 1, 2013

Last Updated

April 13, 2016

Enrollment

196

ACTUAL participants

Conditions

Peripheral Vascular Disease

Interventions

Complete SE Vascular Stent System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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