Status:
UNKNOWN
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
Lead Sponsor:
Segeberger Kliniken GmbH
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
Detailed Description
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus...
Eligibility Criteria
Inclusion
- Clinical inclusion criteria
- Age above 18 years and consentable
- Angiographically proven coronary artery disease
- Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
- Written informed consent
- Angiographic inclusion criteria
- De-novo lesion in a native coronary artery
- Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
- Luminal diameter reduction of 50-100% by visual estimation
- Severe calcification of the target lesion (for definition see appendix)
Exclusion
- Clinical exclusion criteria
- Myocardial infarction (within 1 week)
- Decompensated heart failure
- Limited long term prognosis due to other conditions
- Angiographic exclusion criteria
- Target lesion is in a coronary artery bypass graft
- Target lesion is an in-stent restenosis
- Target vessel thrombus
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04014595
Start Date
January 1 2019
End Date
July 31 2025
Last Update
June 8 2022
Active Locations (1)
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1
Herzzentrum Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795