Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) with stentplacement vs. standard PTA with stentplacement for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery (SFA). The RAPID trial.

Phase 4

Recruiting

Conditions: Atherosclerosis of the superficial femoral artery
10003216

Registration Number: NL-OMON40039

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 176

Inclusion Criteria

- Age over 18
- Symptomatic, atherosclerotic intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery.
- Rutherford class 2-6
- At least one patent below-the-knee artery with uninterrupted flow to the pedal arch.
- Signed informed consent
- Randomization will be performed after advancement of a guide wire across the target SFA lesion with use of an automated web-based randomization tool.

Exclusion Criteria

- Life expectancy less than one year.
- Previous endovascular or surgical treatment of the target superficial femoral artery
- Inability to comply with the follow-up schedule.
- Mental disability that hinders the ability to understand and comply with the informed consent.
- Pregnancy or breast-feeding.
- Severe renal failure (e-GFR <30 mL/min/1.73 m2).
- Known allergy to iodinated contrast agents.
- Contra-indication for anti-coagulation (Aspirin as well as Clopidogrel).
- (Acute) limb ischemia caused by SFA or popliteal artery aneurysmal disease
- Obstruction caused by SFA or popliteal artery dissections

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is absence of binary restenosis rate.<br /><br>Main study parameters are age, gender, relevant co-morbidity, and several<br /><br>disease and procedure related parameters. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are reoclusion rate, target-lesion revascularization rate,<br /><br>clinical success, hemodynamic success, major amputation rate, complication<br /><br>rate, mortality rate and cost-effectiveness. , </p><br>