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

Primary Purpose

Calcified Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Super High Pressure Balloon (OPN NC)
Intravascular lithotripsy (IVL)
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcified Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität BochumRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Deutsches Herzzentrum MuenchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Super high-pressure balloon (OPN NC)

Intravascular lithotripsy (IVL)

Arm Description

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

Patients will be treated with intravascular lithotripsy (IVL).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2021
Last Updated
September 12, 2023
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Abbott Medical Devices, SIS Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT05072730
Brief Title
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Abbott Medical Devices, SIS Medical AG

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Detailed information is provided elsewhere.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcified Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Super high-pressure balloon (OPN NC)
Arm Type
Experimental
Arm Description
Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).
Arm Title
Intravascular lithotripsy (IVL)
Arm Type
Experimental
Arm Description
Patients will be treated with intravascular lithotripsy (IVL).
Intervention Type
Device
Intervention Name(s)
Super High Pressure Balloon (OPN NC)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intravascular lithotripsy (IVL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Final angiographic minimal lumen diameter
Description
The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory.
Time Frame
Intraprocedural.
Secondary Outcome Measure Information:
Title
Angiographic Success
Description
Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow.
Time Frame
Intraprocedural.
Title
Procedural Success
Description
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.
Time Frame
During index hospitalization, assessed up to 30 days.
Title
Strategy Success
Description
Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy
Time Frame
Intraprocedural.
Title
Acute lumen gain
Description
Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD.
Time Frame
Intraprocedural.
Title
Complementary lesion preparation
Description
Need for complementary lesion preparation with rotational atherectomy
Time Frame
Intraprocedural.
Title
MACE rates
Description
Occurrence of major adverse cardiac event (MACE) up to 30 days.
Time Frame
30 days.
Title
Stent expansion as assessed by OCT imaging.
Description
Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging.
Time Frame
Intraprocedural.
Title
Cost-effectiveness analysis
Description
Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation.
Time Frame
Intraprocedural.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Rheude, MD
Phone
+49 89 1218 2985
Email
rheude@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Cassese, MD, PhD
Organizational Affiliation
Deutsches Herzzentrum Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
City
Bad Oeynhausen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ayoub, MD
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Leistner, Prof. MD
Facility Name
Deutsches Herzzentrum Muenchen
City
Muenchen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Cassese, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

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