Overview

This trial is active, not recruiting.

Condition atherosclerosis of native arteries of the extremities, unspecified
Treatment stent implantation
Phase phase 3
Sponsor Boston Scientific Corporation
Start date April 2011
End date July 2014
Trial size 300 participants
Trial identifier NCT01292928, G100291

Summary

The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Stent implantation into SFA/PPA
stent implantation
Stent implantation during the index procedure.

Primary Outcomes

Measure
Safety Rate/Vessel patency
time frame: 12 months

Secondary Outcomes

Measure
Additional Data
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subjects age 18 and older 2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery: 1. Degree of stenosis >/=70% by visual angiographic assessment 2. Vessel diameter >/= 4 and /=30mm and 3 months prior to stent placement 5. Target lesion located at least three centimeters above the inferior edge of the femur 4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot 5. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits Exclusion Criteria: 1. Previous stent placement in the target vessel 2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease 3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months 4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure 5. History of major amputation in the same limb as the target lesion 6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study 7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. 8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications 9. Platelet count <150,000 mm3 or >600,000 mm3 10. Concomitant renal failure with a serum creatinine >2.0 mg/dL 11. Receiving dialysis or immunosuppressant therapy 12. Pregnancy 13. Current participation in another investigational drug or device clinical study 14. Known allergy to Nitinol 15. Septicemia at the time of the index procedure 16. Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure 17. Target lesion is within or near an aneurysm 18. Acute ischemia and/or acute thrombosis of the SFA/PPA 19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy 20. Perforated vessel as evidenced by extravasation of contrast media 21. Heavily calcified lesions

Additional Information

Official title Stenting of the Superficial Femoral and Proximal Popliteal Arteries With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
Principal investigator Richard J Powell, MD
Description Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global study. Approximately 50 centers located in the United States, Europe, Canada and/or Australia are expected to participate in recruiting patients needing treatment of lesions in their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a minimum of 296 stented segments are treated with the Innova Stent System.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.