Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Occlusive Disease
• Intervention / Treatment: Procedure: Paclitaxel coated balloon angioplasty.; Procedure: Infrapopliteal Primary Drug Eluting Stenting

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Rion, Achaia, Greece, 26500
      • Patras University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Principal Investigator: Stavros Spiliopoulos, MD, PhD, University Hospital of Patras; Principal Investigator: Konstantinos Katsanos, MD, PhD, University Hospital of Patras; Study Chair: Dimitrios Siablis, MD,PhD, University Hospital of Patras; Study Director: Dimitrios Karnabatidis, MD, PhD, University Hospital of Patras; Principal Investigator: Athanasios Diamantopoulos, MD, Patras Univesrity Hospital; Principal Investigator: Panagiotis Kitrou, MD, University Hospital of Patras

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: December 2, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (ESTIMATE): January 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Drug eluting stents; Drug coated balloons
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 20884/25-8-11