Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Arterial Occlusive Disease
- Sponsor
- University of Patras
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Angiographic Binary Restenosis
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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.
Investigators
SIABLIS DIMITRIOS
Professor of RAdiology
University of Patras
Eligibility Criteria
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
Outcomes
Primary Outcomes
Angiographic Binary Restenosis
Time Frame: 6 months
Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up
Secondary Outcomes
- Procedure related complication rates(up to 30 days)
- Limb salvage(6 months)
- Technical success rate(intra-procedural)
- Angiographic Primary Patency(6 months)
- Target lesion revascularization(6 months)