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NCT01558531 Clinical Trial

Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis

Peripheral Arterial Disease Clinical Trial

— DEBATE-ISR  

Official title:
Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01558531
Other study ID # Arezzo006
Secondary ID
Status Suspended
Phase Phase 4
First received March 17, 2012
Last updated February 2, 2015
Start date January 2010

Study information
Verified date February 2015
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 44
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• DEB
paclitaxel-eluting balloon angioplasty
• POBA
conventional balloon angioplasty

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Leonardo Bolognese, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary angiographic binary re-restenosis incidence of angiographic binary re-restenosis 12 months No
Secondary major amputation incidence of major amputation 24 months No
Secondary stent thrombosis incidence of stent thrombosis 24 months No
Secondary target lesion revascularization incidence of target lesion revascularization 24 months No
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