Infrapopliteal Drug Eluting Angioplasty Versus Stenting - Full Text View

Purpose

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.

Condition	Intervention	Phase
Arterial Occlusive Disease	Procedure: Paclitaxel coated balloon angioplasty. Procedure: Infrapopliteal Primary Drug Eluting Stenting	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:

Angiographic Binary Restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up

Secondary Outcome Measures:

Technical success rate [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
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 [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure.
Target lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinically-driven target lesion re-intervention
Limb salvage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Major amputation-free interval of the treated limb at 6 months follow-up
Angiographic Primary Patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Angiographically proven target lesion patency without any additional revascularization procedure

Estimated Enrollment:	50
Study Start Date:	August 2011
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: DES

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517997

Contacts

Contact: Konstantinos Katsanos, MD, PhD	+302613603218	katsanos@med.upatras.gr
Contact: Stavros Spiliopoulos, MD, PhD	+3026130603218	stavspiliop@upatras.gr

Locations

Greece
Patras University Hospital	Recruiting
Rion, Achaia, Greece, 26500
Contact: Konstantinos Katsanos, MD, PhD +3026130603218 katsanos@med.upatras.gr
Contact: Stavros Spiliopoulos, MD, PhD +3026130603218 stavspiliop@upatras.gr

Sponsors and Collaborators

University of Patras

Investigators

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

More Information

No publications provided

Responsible Party:	SIABLIS DIMITRIOS, Professor of RAdiology, University of Patras
ClinicalTrials.gov Identifier:	NCT01517997 History of Changes
Other Study ID Numbers:	20884/25-8-11
Study First Received:	December 2, 2011
Last Updated:	January 14, 2013
Health Authority:	Greece: National Organization of Medicines

Keywords provided by University of Patras:

Drug coated balloons
Drug eluting stents

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)