egflow® Paclitaxel Eluting Balloon (LPEB) with stentplacement versus standard percutaneous transluminal angioplasty with stentplacement for the treatment of occlusive disease of the superficial femoral artery

Not Applicable

Completed

• Conditions: Atherosclerotic lesions of the superficial femoral artery; Circulatory System

• Registration Number: ISRCTN47846578
• Lead Sponsor: St Antonius Hospital Nieuwegein (Netherlands)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23537403 2017 results in https://pubmed.ncbi.nlm.nih.gov/28795638/ (added 25/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-30
• Study Completion: 2014-01-01
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

1. Life expectancy less than one year
2. Previous endovascular or surgical treatment of the target superficial femoral artery
3. Inability to comply with the follow-up schedule.
4. Mental disability that hinders the ability to understand and comply with the informed consent
5. Pregnancy or breast-feeding
6. Severe renal failure [estimated glomerular filtration rate (e-GFR) <30 mL/min/1.73 m^2]
7. Known allergy to iodinated contrast agents
8. Contra-indication for anti-coagulation (aspirin as well as clopidogrel)
9. (Acute) limb ischemia caused by SFA or popliteal artery aneurysmal disease
10. Obstruction caused by SFA or popliteal artery dissections

Study & Design

• Study Type: Interventional
• Study Design: Not specified