Status:
COMPLETED
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
SIS Medical AG
Conditions:
Calcified Coronary Artery Disease (Grade 3)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pres...
Eligibility Criteria
Inclusion
- Age above 18 years and consentable;
- Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
- Angiographically-proven coronary artery disease;
- De novo lesion in a native coronary artery;
- Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
- Calcification of the target lesion as determined by angiography (grade 3);
- Unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
- Written informed consent.
Exclusion
- Myocardial infarction (within 1 week);
- Limited long-term prognosis due to other conditions;
- Target lesion is in a coronary artery bypass graft;
- Target lesion is an in-stent restenosis;
- Target lesion is aorto-ostial;
- Target vessel thrombus.
Key Trial Info
Start Date :
July 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03487432
Start Date
July 20 2018
End Date
October 23 2019
Last Update
November 22 2019
Active Locations (5)
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1
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
2
Segeberger Kliniken GmbH
Bad Segeberg, Germany
3
Herzzentrum Leipzig
Leipzig, Germany
4
Deutsches Herzzentrum Muenchen
München, Germany