Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

Study Overview
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Brief Summary
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Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Detailed Description
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Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.

Official Title
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Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

Conditions
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Stenosis, Occlusion, Restenosis

Intervention / Treatment
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* Device: SeQuent Please OTW
* Device: Eluvia Vascular Stent System
* Device: Nitinol stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PAOD and Rutherford classes 2 - 4 (pain-free walking distance <500 m) eligible for peripheral revascularization by means of PTA peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.) minimum diameter stenosis of ≥70% treatment length at least 15 cm (lesion length at least 13 cm) maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. <50% stenosis) segments in between the lesions extent to >2 cm, otherwise vessel segments will be treated as a single extended lesion eligible for an operative vascular intervention in case of complications during the PTA Exclusion Criteria: Rutherford class 1,5 or 6 more than two stenotic lesions in the target vessel requiring treatment inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion in-stent restenosis of the study lesion strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of >4 cm reference vessel diameter <4 mm and >6 mm guide wire could not be successfully advanced across the lesion lesions below the knee requiring treatment target lesion is located in the PII-segment of the popliteal artery (A.pop.) or within a bypass graft acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion potential loss of leg due to critical or acute ischemia no patent distal run-off vessel medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months female patient who is pregnant or lactating under 18 years of age patients under administrative or judicial custody (§20 Act on medical Devices, Germany) expected life span of less than 24 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug coated balloon catheter<br>PTA with paclitaxel coated SeQuent Please OTW | Device: SeQuent Please OTW<br>* Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter<br>|
| Active Comparator: Drug coated stent<br>PTA with paclitaxel coated Eluvia Vascular Stent System | Device: Eluvia Vascular Stent System<br>* Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent<br>|
| Active Comparator: Uncoated stent<br>PTA with bare nitinol stent (as commonly used in site) | Device: Nitinol stent<br>* Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent diameter stenosis at 1 year post intervention in successfully treated patients | by quantitative angiography | 12 +/- 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss | by quantitative angiography | 12 months | 
| Binary restenosis | by DUS | 6,12, 24, 36 months | 
| Target lesion revascularization | number of re-interventions at target lesion | 6, 12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAOD, drug coated balloon, drug coated stent, percutaneous transluminal angioplasty (PTA)