Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

This study is currently recruiting participants.

Verified January 2013 by University of Patras

Sponsor:

Information provided by (Responsible Party):

SIABLIS DIMITRIOS, University of Patras

ClinicalTrials.gov Identifier:

NCT01517997

First received: December 2, 2011

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2011

Last Updated Date

January 14, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01517997 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 comnpletion of the procedure.
Target lesion revascaluarization [ 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 aditional revascularization procedure

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Infrapopliteal Drug Eluting Angioplasty Versus Stenting

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Arterial Occlusive Disease

Intervention ^ICMJE

Procedure: Paclitaxel coated balloon angioplasty.
Infrapopliteal angioplasty using a paclitaxel coated balloon.

Other Name: DCB
Procedure: Infrapopliteal Primary Drug Eluting Stenting
Infrapopliteal primary stenting using drug-eluting stent(s)

Other Name: DES

Study Arm (s)

Experimental: Drug Coated Balloon (DCB) Arm
Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.

Intervention: Procedure: Paclitaxel coated balloon angioplasty.
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.

Intervention: Procedure: Infrapopliteal Primary Drug Eluting Stenting

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT01517997

Other Study ID Numbers ^ICMJE

20884/25-8-11

Has Data Monitoring Committee

Responsible Party

SIABLIS DIMITRIOS, University of Patras

Study Sponsor ^ICMJE

University of Patras

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Patras

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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