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Infrapopliteal Drug Eluting Angioplasty Versus Stenting

NCT01517997 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-10-09

No results posted yet for this 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.

Conditions

  • Arterial Occlusive Disease

Interventions

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)

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Dimitrios Siablis, MD,PhD · University Hospital of Patras

  • Dimitrios Karnabatidis, MD, PhD · University Hospital of Patras

  • Konstantinos Katsanos, MD, PhD · University Hospital of Patras

  • Stavros Spiliopoulos, MD, PhD · University Hospital of Patras

  • Athanasios Diamantopoulos, MD · Patras Univesrity Hospital

  • Panagiotis Kitrou, MD · University Hospital of Patras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517997 on ClinicalTrials.gov