NCT01517997

Infrapopliteal Drug Eluting Angioplasty Versus Stenting

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Occlusive Disease

Interventions

Type	Name	Description
PROCEDURE	Paclitaxel coated balloon angioplasty.	Infrapopliteal angioplasty using a paclitaxel coated balloon.
PROCEDURE	Infrapopliteal Primary Drug Eluting Stenting	Infrapopliteal primary stenting using drug-eluting stent(s)

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-01-25
• Last updated: 2013-10-09

Locations

1 site across 1 country: Greece