Infrapopliteal Drug Eluting Angioplasty Versus Stenting

Arterial Occlusive Disease Clinical Trial

— IDEAS-I  

Official title:

Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517997
• Other study ID #: 20884/25-8-11
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 2, 2011
• Last updated: October 8, 2013
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Disease
• Arterial Occlusive Diseases

Intervention

Procedure:
• Paclitaxel coated balloon angioplasty.
Infrapopliteal angioplasty using a paclitaxel coated balloon.
• Infrapopliteal Primary Drug Eluting Stenting
Infrapopliteal primary stenting using drug-eluting stent(s)

Locations

Country	Name	City	State
Greece	Patras University Hospital	Rion	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic Binary Restenosis	Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up	6 months	No
Secondary	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	No
Secondary	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	Yes
Secondary	Target lesion revascularization	Clinically-driven target lesion re-intervention	6 months	No
Secondary	Limb salvage	Major amputation-free interval of the treated limb at 6 months follow-up	6 months	Yes
Secondary	Angiographic Primary Patency	Angiographically proven target lesion patency without any additional revascularization procedure	6 months	No