ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

NCT05072730 | Unknown

• 1 other identifier: GE IDE Nr. BA00421
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Calcified Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Angiographic Success

  Intraprocedural.

• Procedural Success

  During index hospitalization, assessed up to 30 days.

• Strategy Success

  Intraprocedural.

• Acute lumen gain

  Intraprocedural.

• Complementary lesion preparation

  Intraprocedural.

Study Arms (2)

Super high-pressure balloon (OPN NC)

EXPERIMENTAL

Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).

Device: Super High Pressure Balloon (OPN NC)

Intravascular lithotripsy (IVL)

EXPERIMENTAL

Patients will be treated with intravascular lithotripsy (IVL).

Device: Intravascular lithotripsy (IVL)

Interventions

Super High Pressure Balloon (OPN NC) DEVICE

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.

Super high-pressure balloon (OPN NC)

Intravascular lithotripsy (IVL) DEVICE

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.

Intravascular lithotripsy (IVL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Abbott Medical Devices: collaborator
• SIS Medical AG: collaborator

Study Sites (4)

Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum

Bad Oeynhausen, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

RECRUITING

MEDICLIN Herzzentrum Lahr

Lahr, 77933, Germany

RECRUITING

Deutsches Herzzentrum Muenchen

München, Germany

RECRUITING

Related Publications (1)

• Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T. Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial. Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30.

  PMID: 36609101 DERIVED

Study Officials

• Salvatore Cassese, MD, PhD

  Deutsches Herzzentrum Munich

  PRINCIPAL INVESTIGATOR

• Tobias Rheude, MD

  Deutsches Herzzentrum Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Rheude, MD

CONTACT

+49 89 1218 2985; rheude@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: October 11, 2021
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)