Status:
COMPLETED
The PREVAIL Study
Lead Sponsor:
Medtronic Vascular
Conditions:
In-stent Restenosis
Ischemic Heart Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary les...
Detailed Description
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries t...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.
- Key Exclusion Criteria
- Acute Myocardial Infarction within the previous 72 hours
- Planned treatment involves a bifurcation
- Three vessel disease
Exclusion
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03260517
Start Date
October 2 2017
End Date
August 1 2019
Last Update
September 30 2019
Active Locations (10)
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1
ZNA Middelheim
Antwerp, Belgium, 2020
2
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
3
CHU Liege
Liège, Belgium, 4000
4
IRCCS Policlinico San Donato
Milan, Italy, 20097