Arterial Occlusive Disease
Conditions
Keywords
Drug coated balloons, Drug eluting stents
Brief summary
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.
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.
Interventions
PROCEDUREPaclitaxel coated balloon angioplasty.
Infrapopliteal angioplasty using a paclitaxel coated balloon.
PROCEDUREInfrapopliteal Primary Drug Eluting Stenting
Infrapopliteal primary stenting using drug-eluting stent(s)
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Binary Restenosis | 6 months | Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | 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 | 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 | 6 months | Clinically-driven target lesion re-intervention |
| Limb salvage | 6 months | Major amputation-free interval of the treated limb at 6 months follow-up |
| Angiographic Primary Patency | 6 months | Angiographically proven target lesion patency without any additional revascularization procedure |
Countries
Greece
Outcome results
None listed