A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC)

German Heart Center Munich

Status: Completed

Conditions: Calcified Coronary Artery Disease (Grade 3)

Treatments: Device: Super High-Pressure NC PTCA Balloon (OPN NC); Device: Scoring PTCA Balloon (NSE Alpha)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03487432

GE IDE Nr. BA00117

Details and patient eligibility

About

The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 years and consentable;
• Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
• Angiographically-proven coronary artery disease;
• De novo lesion in a native coronary artery;
• Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
• Calcification of the target lesion as determined by angiography (grade 3);
• Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
• Written informed consent.

Exclusion criteria

• Myocardial infarction (within 1 week);
• Limited long-term prognosis due to other conditions;
• Target lesion is in a coronary artery bypass graft;
• Target lesion is an in-stent restenosis;
• Target lesion is aorto-ostial;
• Target vessel thrombus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

OPN NC

Experimental group

Description:

Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)

Treatment:

Device: Super High-Pressure NC PTCA Balloon (OPN NC)

NSE Alpha

Experimental group

Description:

Patients receiving a Scoring PTCA Balloon (NSE Alpha)

Treatment:

Device: Scoring PTCA Balloon (NSE Alpha)