Infrapopliteal Drug Eluting Angioplasty Versus Stenting

Last updated: October 8, 2013
Sponsor: University of Patras
Overall Status: Completed

Phase

2/3

Condition

Peripheral Arterial Disease (Pad)

Peripheral Vascular Disease

Claudication

Treatment

N/A

Clinical Study ID

NCT01517997
20884/25-8-11
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tibialvessels.

Exclusion

Exclusion Criteria:

  • Lesion length < 70 mm or > 220 mm.

  • Lesions situated in the distal third of the tibial vessels

Study Design

Total Participants: 50
Study Start date:
August 01, 2011
Estimated Completion Date:
September 30, 2013

Study 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.

Connect with a study center

  • Patras University Hospital

    Rion, Achaia 26500
    Greece

    Site Not Available

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