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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated Balloon (DCB) Arm | Experimental | Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon. |
|
| Drug Eluting Stents (DES) Arm | Active Comparator | Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel coated balloon angioplasty. | Procedure | Infrapopliteal angioplasty using a paclitaxel coated balloon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic Binary Restenosis | Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | 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. | intra-procedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Siablis, MD,PhD | University Hospital of Patras | Study Chair |
| Dimitrios Karnabatidis, MD, PhD | University Hospital of Patras | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patras University Hospital | Rio | Achaia | 26500 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25234679 | Derived | 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. |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Infrapopliteal Primary Drug Eluting Stenting | Procedure | Infrapopliteal primary stenting using drug-eluting stent(s) |
|
|
| Procedure related complication rates |
procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure. |
| up to 30 days |
| Target lesion revascularization | Clinically-driven target lesion re-intervention | 6 months |
| Limb salvage | Major amputation-free interval of the treated limb at 6 months follow-up | 6 months |
| Angiographic Primary Patency | Angiographically proven target lesion patency without any additional revascularization procedure | 6 months |