Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)
|ClinicalTrials.gov Identifier: NCT01517997|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Disease||Procedure: Paclitaxel coated balloon angioplasty. Procedure: Infrapopliteal Primary Drug Eluting Stenting||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Angiographic Binary Restenosis [ Time Frame: 6 months ]Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517997
|Patras University Hospital|
|Rion, Achaia, Greece, 26500|
|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|