Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

University of Patras

Status and phase: Completed; Phase 3; Phase 2

Conditions: Arterial Occlusive Disease

Treatments: Procedure: Paclitaxel coated balloon angioplasty.; Procedure: Infrapopliteal Primary Drug Eluting Stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01517997

20884/25-8-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Drug Coated Balloon (DCB) Arm

Experimental group

Description:

Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.

Treatment:

Procedure: Paclitaxel coated balloon angioplasty.

Drug Eluting Stents (DES) Arm

Active Comparator group

Description:

Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.

Treatment:

Procedure: Infrapopliteal Primary Drug Eluting Stenting