PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

Last updated: June 3, 2022
Sponsor: Segeberger Kliniken GmbH
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Chest Pain

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04014595
SK 110 -- 168/11
  • Ages > 18
  • All Genders

Study Summary

A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria: Clinical inclusion criteria

  1. Age above 18 years and consentable
  2. Angiographically proven coronary artery disease
  3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functionalstress testing or fractional flow reserve
  4. Written informed consent Angiographic inclusion criteria
  5. De-novo lesion in a native coronary artery
  6. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
  7. Luminal diameter reduction of 50-100% by visual estimation
  8. Severe calcification of the target lesion (for definition see appendix)

Exclusion

Exclusion Criteria: Clinical exclusion criteria

  1. Myocardial infarction (within 1 week)
  2. Decompensated heart failure
  3. Limited long term prognosis due to other conditions Angiographic exclusion criteria
  4. Target lesion is in a coronary artery bypass graft
  5. Target lesion is an in-stent restenosis
  6. Target vessel thrombus

Study Design

Total Participants: 100
Study Start date:
January 01, 2019
Estimated Completion Date:
July 31, 2025

Study 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-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

Connect with a study center

  • Herzzentrum Segeberger Kliniken GmbH

    Bad Segeberg, 23795
    Germany

    Site Not Available

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