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

German Heart Center Munich

Status: Enrolling

Conditions: Calcified Coronary Artery Disease

Treatments: Device: Super High Pressure Balloon (OPN NC); Device: Intravascular lithotripsy (IVL)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05072730

GE IDE Nr. BA00421

Details and patient eligibility

About

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.

Full description

Detailed information is provided elsewhere.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Super high-pressure balloon (OPN NC)

Experimental group

Description:

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

Treatment:

Device: Super High Pressure Balloon (OPN NC)

Intravascular lithotripsy (IVL)

Experimental group

Description:

Patients will be treated with intravascular lithotripsy (IVL).

Treatment:

Device: Intravascular lithotripsy (IVL)