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

Conditions

Atherosclerotic lesions of the superficial femoral artery Circulatory System

de Boer SW, van den Heuvel DAF, de Vries-Werson DAB, Vos JA, Fioole B, Vroegindeweij D, Elgersma OE, Tutein Nolthenius RP, Heyligers JMM, Bosma GPT, de Leeuw B, Bouwman LH, Böckler D, Dovzhanskiy DI, Vos FWF, Vink TWF, Hooijboer PGA, Hissink RJ, de Vries JPM.

2017-08-1031 citations

10.1177/1526602817725062

Randomized trial of Legflow(®) paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial.

Karimi A, de Boer SW, van den Heuvel DA, Fioole B, Vroegindeweij D, Heyligers JM, Lohle PN, Elgersma O, Nolthenius RP, Vos JA, de Vries JP.

2013-03-2810 citations

10.1186/1745-6215-14-87

Interventions

The intervention group will undergo endovascular dilatation of intermediate and long lesions of the SFA with the LegFlow® Paclitaxel eluting balloon followed by placement of a nitinol selfexpandable s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 18 2. Symptomatic, atherosclerotic intermediate (>5 cm and 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

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

Design outcomes

Primary

Measure	Time frame
Absence of binary restenosis, measured with duplex ultrasound (DUS), and if indicated with digital subtraction angiography (DSA), at 1, 6, 12 and 24 months follow-up and unplanned visits	—

Secondary

Measure	Time frame
1. Immediate outcome: Ankle Brachial Index (ABI), toe pressures, angiography 2. Clinical outcome: periferal artery questionnaire 3. Hemodynamic outcome: ankle-brachial index (ABI), Toe pressures 4. Reocclusion rate: DUS, DSA 5. Target-lesion revascularization: Follow-up 6. Target-extremity revascularization: Follow-up 7. Mortality rate: Follow-up 8. Amputation rate : Follow-up 9. Rate of device-specific problems: Follow-up with DUS, DSA when indicated All endpoints will be scored at regular follow-up and during unplanned visits.	—

Measure

Time frame

1. Immediate outcome: Ankle Brachial Index (ABI), toe pressures, angiography 2. Clinical outcome: periferal artery questionnaire 3. Hemodynamic outcome: ankle-brachial index (ABI), Toe pressures 4. Reocclusion rate: DUS, DSA 5. Target-lesion revascularization: Follow-up 6. Target-extremity revascularization: Follow-up 7. Mortality rate: Follow-up 8. Amputation rate : Follow-up 9. Rate of device-specific problems: Follow-up with DUS, DSA when indicated All endpoints will be scored at regular follow-up and during unplanned visits.

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Countries

Netherlands

Outcome results

None listed