A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

Calcified Coronary Artery Disease (Grade 3) Clinical Trial

— ISAR-CALC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487432
• Other study ID #: GE IDE Nr. BA00117
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: October 23, 2019

Study information

• Verified date: November 2019
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calcified Coronary Artery Disease (Grade 3)
• Coronary Artery Disease

Intervention

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.
• Scoring PTCA Balloon (NSE Alpha)
Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum Muenchen	Muenchen
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	SIS Medical AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Acute lumen gain,	Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)	intraprocedural
Secondary	Complementary lesion preparations	Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])	intraprocedural
Secondary	Rate of vessel perforation	Rate of vessel perforation	intraprocedural
Secondary	Procedure duration	Procedure duration in min	intraprocedural
Secondary	Contrast volume	Contrast volume in mL	intraprocedural