ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

Last updated: January 7, 2024
Sponsor: Deutsches Herzzentrum Muenchen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiovascular Disease

Chest Pain

Treatment

Intravascular lithotripsy (IVL)

Super High Pressure Balloon (OPN NC)

Clinical Study ID

NCT05072730
GE IDE Nr. BA00421
  • Ages > 18
  • All Genders

Study Summary

The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above 18 years and able to give consent
  • Persistent angina despite medical therapy and/or evidence of inducible ischemia
  • De-novo lesion in a native coronary artery
  • Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm byvisual estimation
  • Severe calcification of the target lesion as determined by visual estimation atcoronary angiography
  • Unsuccessful lesion preparation with standard non-compliant balloon (< 30% reductionof baseline diameter stenosis at maximal pressure)
  • Written informed consent.

Exclusion

Exclusion Criteria:

  • Target lesion is located in a coronary artery bypass graft
  • Target lesion is an in-stent restenosis
  • Target lesion is a chronic total occlusion
  • Target vessel thrombus
  • Limited long-term prognosis due to other comorbid conditions with life expectancy <12months

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Intravascular lithotripsy (IVL)
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
September 01, 2024

Study Description

Detailed information is provided elsewhere.

Connect with a study center

  • Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum

    Bad Oeynhausen,
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt am Main,
    Germany

    Active - Recruiting

  • MEDICLIN Herzzentrum Lahr

    Lahr, 77933
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum Muenchen

    Muenchen,
    Germany

    Active - Recruiting

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