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

A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions

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)).

Study Overview

• Status: Completed
• Conditions: Calcified Coronary Artery Disease (Grade 3)
• Intervention / Treatment: Device: Super High-Pressure NC PTCA Balloon (OPN NC); Device: Scoring PTCA Balloon (NSE Alpha)

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Bad Segeberg, Germany
    • Segeberger Kliniken GmbH
  • Leipzig, Germany
    • Herzzentrum Leipzig
  • Muenchen, Germany
    • Deutsches Herzzentrum Muenchen
• Switzerland
  • Luzern, Switzerland
    • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OPN NC; Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)	Device: Super High-Pressure NC PTCA Balloon (OPN NC); Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
EXPERIMENTAL: NSE Alpha; Patients receiving a Scoring PTCA Balloon (NSE Alpha)	Device: Scoring PTCA Balloon (NSE Alpha); Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent expansion index (SEI)	Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis	intraprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic Success	'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow	intraprocedural
Procedural Success	'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG])	30 days
Strategy Success	'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA])	intraprocedural
Acute lumen gain,	Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)	intraprocedural
Complementary lesion preparations	Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])	intraprocedural
Rate of vessel perforation	Rate of vessel perforation	intraprocedural
Procedure duration	Procedure duration in min	intraprocedural
Contrast volume	Contrast volume in mL	intraprocedural

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: SIS Medical AG
• Investigators: Study Chair: Robert A Byrne, MD BCh PhD, Deutsches Herzzentrum Muenchen; Principal Investigator: Salvatore Cassese, MD PhD, Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2018
• Primary Completion (ACTUAL): September 23, 2019
• Study Completion (ACTUAL): October 23, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: GE IDE Nr. BA00117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No