Infrapopliteal Drug Eluting Angioplasty Versus Stenting

Study Overview
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Brief Summary
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In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.

Detailed Description
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Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.

Official Title
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Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

Conditions
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Arterial Occlusive Disease

Intervention / Treatment
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* Procedure: Paclitaxel coated balloon angioplasty.
* Procedure: Infrapopliteal Primary Drug Eluting Stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angiographically documented infrapopliteal disease. Rutherford category of peripheral arterial disease between class 3 to 6 Lesion length between 70 to 220 mm Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels. Exclusion Criteria: Lesion length < 70 mm or > 220 mm. Lesions situated in the distal third of the tibial vessels

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Coated Balloon (DCB) Arm<br>Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon. | Procedure: Paclitaxel coated balloon angioplasty.<br>* Infrapopliteal angioplasty using a paclitaxel coated balloon.<br>* Other names: DCB;|
| Active Comparator: Drug Eluting Stents (DES) Arm<br>Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent. | Procedure: Infrapopliteal Primary Drug Eluting Stenting<br>* Infrapopliteal primary stenting using drug-eluting stent(s)<br>* Other names: DES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Binary Restenosis | Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Successful balloon angioplasty without stent use due to flow limiting dissection or/and <30% remaining target lesion stenosis in the DCB arm and successful balloon angioplasty without flow limiting dissection or/and <30% remaining target lesion stenosis in the DES arm. | intra-procedural | 
| Procedure related complication rates | procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure. | up to 30 days | 
| Target lesion revascularization | Clinically-driven target lesion re-intervention | 6 months | 
| Limb salvage | Major amputation-free interval of the treated limb at 6 months follow-up | 6 months | 
| Angiographic Primary Patency | Angiographically proven target lesion patency without any additional revascularization procedure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug coated balloons, Drug eluting stents