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Infrapopliteal Drug Eluting Angioplasty Versus Stenting

NCT ID: NCT01517997

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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

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Arterial Occlusive Disease

Keywords

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Drug coated balloons Drug eluting stents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Drug Coated Balloon (DCB) Arm

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

Group Type EXPERIMENTAL

Paclitaxel coated balloon angioplasty.

Intervention Type PROCEDURE

Infrapopliteal angioplasty using a paclitaxel coated balloon.

Drug Eluting Stents (DES) Arm

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

Group Type ACTIVE_COMPARATOR

Infrapopliteal Primary Drug Eluting Stenting

Intervention Type PROCEDURE

Infrapopliteal primary stenting using drug-eluting stent(s)

Interventions

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Paclitaxel coated balloon angioplasty.

Infrapopliteal angioplasty using a paclitaxel coated balloon.

Intervention Type PROCEDURE

Infrapopliteal Primary Drug Eluting Stenting

Infrapopliteal primary stenting using drug-eluting stent(s)

Intervention Type PROCEDURE

Other Intervention Names

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DCB DES

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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SIABLIS DIMITRIOS

Professor of RAdiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitrios Siablis, MD,PhD

Role: STUDY_CHAIR

University Hospital of Patras

Dimitrios Karnabatidis, MD, PhD

Role: STUDY_DIRECTOR

University Hospital of Patras

Konstantinos Katsanos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Stavros Spiliopoulos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Athanasios Diamantopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Patras Univesrity Hospital

Panagiotis Kitrou, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Locations

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Patras University Hospital

Rio, Achaia, Greece

Site Status

Countries

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Greece

References

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Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014 Sep;7(9):1048-56. doi: 10.1016/j.jcin.2014.04.015.

Reference Type DERIVED
PMID: 25234679 (View on PubMed)

Other Identifiers

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20884/25-8-11

Identifier Type: -

Identifier Source: org_study_id