Clinical trial NCT05072730: ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
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
Overall status: RECRUITING
Phase: NA
Conditions: Calcified Coronary Artery Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: SIS Medical AG
First posted: 2021-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Final angiographic minimal lumen diameter
timeFrame: Intraprocedural.
Secondary outcomes:
measure: Angiographic Success
timeFrame: Intraprocedural.
measure: Procedural Success
timeFrame: During index hospitalization, assessed up to 30 days.
measure: Strategy Success
timeFrame: Intraprocedural.
measure: Acute lumen gain
timeFrame: Intraprocedural.
measure: Complementary lesion preparation
timeFrame: Intraprocedural.
measure: MACE rates
timeFrame: 30 days.
measure: Stent expansion as assessed by OCT imaging.
timeFrame: Intraprocedural.
measure: Cost-effectiveness analysis
timeFrame: Intraprocedural.
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Lahr
country: Germany
facility: MEDICLIN Herzzentrum Lahr
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Munich
name: Salvatore Cassese, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum Munich
name: Tobias Rheude, MD
role: PRINCIPAL_INVESTIGATOR
References: