Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

NCT ID: NCT01816854

Last Updated: 2018-12-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-08
• Study Completion Date: 2017-03-29

Brief Summary

In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.

Conditions

Atherosclerotic Heart Disease

Keywords

Peripheral artery disease; SFA; PPA; Self-expandable nitinol stent; Endovascular; Stenosis; Primary pantency

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with PAD

Stenting

Intervention Type: DEVICE

Interventions

Stenting

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient must sign informed consent prior to the index-procedure
• Patient must be older than 18 years
• Patient must be compliant with follow-up dates at 1 month and 12 months
• Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
• Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
• Reference vessel diameter ≥4.5 and ≤6.5 mm (visual estimate)
• Patients with a TASC A, B or C lesion
• Diameter stenosis of target lesion >50% or chronic occlusions
• Inflow arteries are free of hemodynamically significant obstruction (i.e. ≥50%)
• The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. ≥50%)
• At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography

Exclusion Criteria

• Patients with Rutherford 1 and 6
• Patiens with Serum creatinine > 2.0 mg/dL or renal dialysis
• Patient takes esomeprazole or omeprazole
• Patient is pregnant
• Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
• Target lesion cannot be crossed with a guidewire
• Target lesion is located in the popliteal artery
• Patients with a nickel-titanium allergy
• Patients with an aneurysm in the superficial femoral artery and popliteal artery
• Patients with a TASC D lesion
• Patients with a life expectancy <1 year
• Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted
• Patients with previous bypass surgery in the SFA
• Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)
• Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure
• Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

be Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Hendriks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

BM-HERO-07-001

Identifier Type: -

Identifier Source: org_study_id