Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; Vascular Disease; Peripheral Vascular Disease; Cardiovascular Diseases; PAD

• Registration Number: NCT01355406
• Lead Sponsor: Cordis Corporation

Brief Summary

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.

The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-18
• Study Start: 2011-09-16
• Primary Completion: 2016-01-15
• Disposition First Submitted: 2017-10-13
• Disposition First Submitted QC: 2017-10-13
• Disposition First Posted: 2017-10-17
• Study Completion: 2018-04-10
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

All subjects must meet the following criteria:

1. Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening.
2. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
3. Rutherford Classification Category 2-4
4. De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint
5. Disease segment length ≤ 180 mm
6. >70% diameter stenosis and/or occlusion based on site-determined visual angiography
7. Patent ipsilateral iliac artery
8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
9. Target reference vessel diameter 3.5-7.5 mm.
10. Projected life expectancy of 12 months or greater
11. Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
12. Patient is willing and able to provide signed informed consent

Exclusion Criteria

Any subject meeting any of the following criteria will be excluded from the study.

1. Target vessel previously treated with a stent
2. Target lesion within 1.5 cm of the ostium of the SFA
3. Rutherford Classification Category 0,1,5 or 6
4. Inability to tolerate antithrombotic or antiplatelet therapies
5. Pregnancy (female of child-bearing age confirmed pregnant)
6. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
7. Serum creatinine > 2.5 mg/dL
8. Myocardial infarction or stroke within 30 days of treatment date
9. Known hypercoagulable state
10. Known bleeding diathesis
11. Untreated angiographically-evident thrombus in target vessel
12. Patients currently enrolled in any other clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is vessel patency at 12 months.	12 Months	The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure.
The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.	30 Days	The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.

Trial Locations

Locations (38)

Abrazo Health Care Clinical & Trans. Research; 🇺🇸 Phoenix, Arizona, United States

Yuma Regional Medical Center; 🇺🇸 Yuma, Arizona, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Yale University/New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Florida Research Network; 🇺🇸 Gainesville, Florida, United States

Memorial Hospital; 🇺🇸 Jacksonville, Florida, United States

Mount Sinai Miami Medical Center; 🇺🇸 Miami Beach, Florida, United States

Baptist Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

Florida Hospital Pepin Heart Institute; 🇺🇸 Tampa, Florida, United States

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