ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2 (ISAR-CALC2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Calcified Coronary Artery Disease
• Intervention / Treatment: Device: Super High Pressure Balloon (OPN NC); Device: Intravascular lithotripsy (IVL)

Detailed Description

Detailed information is provided elsewhere.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Rheude, MD; Phone Number: +49 89 1218 2985; Email: rheude@dhm.mhn.de

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
    • Contact: Mohamed Ayoub, MD
  • Frankfurt am Main, Germany
    • Recruiting
    • Universitätsklinikum Frankfurt
    • Contact: David M Leistner, Prof. MD
  • Lahr, Germany, 77933
    • Recruiting
    • MediClin Herzzentrum Lahr
    • Contact: Kambis Mashayekhi, MD
  • Muenchen, Germany
    • Recruiting
    • Deutsches Herzzentrum Muenchen
    • Contact: Salvatore Cassese, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Super high-pressure balloon (OPN NC); Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).	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.
Experimental: Intravascular lithotripsy (IVL); Patients will be treated with intravascular lithotripsy (IVL).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic Success	Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow.	Intraprocedural.
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.
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.
Acute lumen gain	Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD.	Intraprocedural.
Complementary lesion preparation	Need for complementary lesion preparation with rotational atherectomy	Intraprocedural.
MACE rates	Occurrence of major adverse cardiac event (MACE) up to 30 days.	30 days.
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.
Cost-effectiveness analysis	Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation.	Intraprocedural.

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Abbott Medical Devices; SIS Medical AG
• Investigators: Principal Investigator: Salvatore Cassese, MD, PhD, Deutsches Herzzentrum Munich; Principal Investigator: Tobias Rheude, MD, Deutsches Herzzentrum Munich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: GE IDE Nr. BA00421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No