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Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

This study has been completed.
Information provided by (Responsible Party):
SIABLIS DIMITRIOS, University of Patras Identifier:
First received: December 2, 2011
Last updated: October 8, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Arterial Occlusive Disease
Procedure: Paclitaxel coated balloon angioplasty.
Procedure: Infrapopliteal Primary Drug Eluting Stenting
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Angiographic Binary Restenosis [ Time Frame: 6 months ]
    Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up

Secondary Outcome Measures:
  • Technical success rate [ Time Frame: 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.

  • Procedure related complication rates [ Time Frame: 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.

  • Target lesion revascularization [ Time Frame: 6 months ]
    Clinically-driven target lesion re-intervention

  • Limb salvage [ Time Frame: 6 months ]
    Major amputation-free interval of the treated limb at 6 months follow-up

  • Angiographic Primary Patency [ Time Frame: 6 months ]
    Angiographically proven target lesion patency without any additional revascularization procedure

Enrollment: 50
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Coated Balloon (DCB) Arm
Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.
Procedure: Paclitaxel coated balloon angioplasty.
Infrapopliteal angioplasty using a paclitaxel coated balloon.
Other Name: DCB
Active Comparator: Drug Eluting Stents (DES) Arm
Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.
Procedure: Infrapopliteal Primary Drug Eluting Stenting
Infrapopliteal primary stenting using drug-eluting stent(s)
Other Name: DES

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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01517997

Patras University Hospital
Rion, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras
Study Chair: Dimitrios Siablis, MD,PhD University Hospital of Patras
Study Director: Dimitrios Karnabatidis, MD, PhD University Hospital of Patras
Principal Investigator: Konstantinos Katsanos, MD, PhD University Hospital of Patras
Principal Investigator: Stavros Spiliopoulos, MD, PhD University Hospital of Patras
Principal Investigator: Athanasios Diamantopoulos, MD Patras Univesrity Hospital
Principal Investigator: Panagiotis Kitrou, MD University Hospital of Patras
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SIABLIS DIMITRIOS, Professor of RAdiology, University of Patras Identifier: NCT01517997     History of Changes
Other Study ID Numbers: 20884/25-8-11
Study First Received: December 2, 2011
Last Updated: October 8, 2013

Keywords provided by University of Patras:
Drug coated balloons
Drug eluting stents

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017