Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|