Study Stopped
slow enrollment
Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis
DEBATE-ISR
Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
1 other identifier
observational
44
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 17, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedFebruary 3, 2015
February 1, 2015
1.9 years
March 17, 2012
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
angiographic binary re-restenosis
incidence of angiographic binary re-restenosis
12 months
Secondary Outcomes (3)
major amputation
24 months
stent thrombosis
24 months
target lesion revascularization
24 months
Study Arms (2)
DEB
paclitaxel-eluting balloon angioplasty
conventional PTA
historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009)
Interventions
Eligibility Criteria
Patients referring to our institution for peripheral artery disease
You may qualify if:
- age\>18 years
- intermittent claudication (Fontane III or IV)
- angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle
You may not qualify if:
- allergy to Paclitaxel
- contraindication for combined antiplatelet treatment
- life expectancy \<1 year
- hypersensitivity or contraindication to one of the study drugs
- lack of consent
- need for amputation
- angiographic evidence of stent fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, 52100, Italy
Related Publications (2)
Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28.
PMID: 26511896DERIVEDLiistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1.
PMID: 24502477DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 17, 2012
First Posted
March 20, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Last Updated
February 3, 2015
Record last verified: 2015-02