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Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SIABLIS DIMITRIOS, University of Patras
ClinicalTrials.gov Identifier:
NCT01517997
First received: December 2, 2011
Last updated: October 8, 2013
Last verified: October 2013

December 2, 2011
October 8, 2013
August 2011
September 2013   (final data collection date for primary outcome measure)
Angiographic Binary Restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up
Same as current
Complete list of historical versions of study NCT01517997 on ClinicalTrials.gov Archive Site
  • Technical success rate [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Clinically-driven target lesion re-intervention
  • Limb salvage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Major amputation-free interval of the treated limb at 6 months follow-up
  • Angiographic Primary Patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Angiographically proven target lesion patency without any additional revascularization procedure
  • Technical success rate [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    procedure related major and minor complication rates identified during the procedure or within 30 days after the comnpletion of the procedure.
  • Target lesion revascaluarization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinically-driven target lesion re-intervention
  • Limb salvage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Major amputation-free interval of the treated limb at 6 months follow-up
  • Angiographic Primary Patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Angiographically proven target lesion patency without any aditional revascularization procedure
Not Provided
Not Provided
 
Infrapopliteal Drug Eluting Angioplasty Versus Stenting
Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Arterial Occlusive Disease
  • Procedure: Paclitaxel coated balloon angioplasty.
    Infrapopliteal angioplasty using a paclitaxel coated balloon.
    Other Name: DCB
  • Procedure: Infrapopliteal Primary Drug Eluting Stenting
    Infrapopliteal primary stenting using drug-eluting stent(s)
    Other Name: DES
  • Experimental: Drug Coated Balloon (DCB) Arm
    Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.
    Intervention: Procedure: Paclitaxel coated balloon angioplasty.
  • 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.
    Intervention: Procedure: Infrapopliteal Primary Drug Eluting Stenting
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01517997
20884/25-8-11
No
SIABLIS DIMITRIOS, University of Patras
University of Patras
Not Provided
Study Chair: Dimitrios Siablis, MD,PhD Patras University Hospital
Study Director: Dimitrios Karnabatidis, MD, PhD Patras University Hospital
Principal Investigator: Konstantinos Katsanos, MD, PhD Patras University Hospital
Principal Investigator: Stavros Spiliopoulos, MD, PhD Patras University Hospital
Principal Investigator: Athanasios Diamantopoulos, MD Patras Univesrity Hospital
Principal Investigator: Panagiotis Kitrou, MD Patras University Hospital
University of Patras
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP