Infrapopliteal Drug Eluting Angioplasty Versus Stenting

Phase 2

Completed

• Conditions: Arterial Occlusive Disease
• Interventions: Procedure: Paclitaxel coated balloon angioplasty.; Procedure: Infrapopliteal Primary Drug Eluting Stenting

• Registration Number: NCT01517997
• Lead Sponsor: University of Patras

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Coated Balloon (DCB) Arm	Paclitaxel coated balloon angioplasty.	Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.
Drug Eluting Stents (DES) Arm	Infrapopliteal Primary Drug Eluting Stenting	Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.

Primary Outcome Measures

Name	Time	Method
Angiographic Binary Restenosis	6 months	Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Procedure related complication rates	up to 30 days	procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure.
Limb salvage	6 months	Major amputation-free interval of the treated limb at 6 months follow-up
Technical success rate	intra-procedural	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.
Angiographic Primary Patency	6 months	Angiographically proven target lesion patency without any additional revascularization procedure
Target lesion revascularization	6 months	Clinically-driven target lesion re-intervention

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Rion, Achaia, Greece