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NCT05072730 Clinical Trial

ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

Calcified Coronary Artery Disease Clinical Trial

— ISAR-CALC2  

Official title:
Super High-Pressure Balloon Versus Intravascular Lithotripsy for Severely Calcified Coronary Lesions: The ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC) 2 Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05072730
Other study ID # GE IDE Nr. BA00421
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date September 1, 2024

Study information
Verified date January 2024
Source Deutsches Herzzentrum Muenchen
Contact Tobias Rheude, MD
Phone +49 89 1218 2985
Email rheude@dhm.mhn.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Detailed information is provided elsewhere.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 by visual estimation - Severe calcification of the target lesion as determined by visual estimation at coronary angiography - Unsuccessful lesion preparation with standard non-compliant balloon (< 30% reduction of baseline diameter stenosis at maximal pressure) - Written informed consent. 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 <12 months

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Super High Pressure Balloon (OPN NC)
Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with OPN balloon. Optional additional pre-dilatation with OPN/standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with OPN balloon or standard NC balloon is permitted at the operator´s discretion.
• Intravascular lithotripsy (IVL)
Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with IVL balloon. Optional additional pre-dilatation with standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with standard NC balloon is permitted at the operator´s discretion.

Locations
Country Name City State
Germany Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum Bad Oeynhausen
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany MEDICLIN Herzzentrum Lahr Lahr
Germany Deutsches Herzzentrum Muenchen Muenchen

Sponsors (3)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen Abbott Medical Devices, SIS Medical AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Final angiographic minimal lumen diameter The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory. Intraprocedural.
Secondary Angiographic Success Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Intraprocedural.
Secondary Procedural Success Defined as angiographic success without the occurrence of major adverse cardiac event (MACE), a composite of cardiac death, target-vessel related MI and repeat target-vessel revascularization, during index hospitalization. During index hospitalization, assessed up to 30 days.
Secondary Strategy Success Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy Intraprocedural.
Secondary Acute lumen gain Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD. Intraprocedural.
Secondary Complementary lesion preparation Need for complementary lesion preparation with rotational atherectomy Intraprocedural.
Secondary MACE rates Occurrence of major adverse cardiac event (MACE) up to 30 days. 30 days.
Secondary Stent expansion as assessed by OCT imaging. Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging. Intraprocedural.
Secondary Cost-effectiveness analysis Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation. Intraprocedural.