Clinical trial NCT01517997: Infrapopliteal Drug Eluting Angioplasty Versus Stenting
Official title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arterial Occlusive Disease
Keywords: Drug coated balloons
Drug eluting stents
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Angiographic Binary Restenosis
timeFrame: 6 months
Secondary outcomes:
measure: Technical success rate
timeFrame: intra-procedural
measure: Procedure related complication rates
timeFrame: up to 30 days
measure: Target lesion revascularization
timeFrame: 6 months
measure: Limb salvage
timeFrame: 6 months
measure: Angiographic Primary Patency
timeFrame: 6 months
Other outcomes:
Locations:
city: Rion
country: Greece
facility: Patras University Hospital
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Dimitrios Siablis, MD,PhD
role: STUDY_CHAIR
affiliation: University Hospital of Patras
name: Dimitrios Karnabatidis, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Patras
name: Konstantinos Katsanos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Stavros Spiliopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Patras Univesrity Hospital
name: Athanasios Diamantopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Panagiotis Kitrou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.