A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

Deutsches Herzzentrum Muenchen74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Calcified Coronary Artery Disease (Grade 3)

Interventions

Super High-Pressure NC PTCA Balloon (OPN NC)DEVICE

Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

Scoring PTCA Balloon (NSE Alpha)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Germany

Segeberger Kliniken GmbH

Bad Segeberg, Germany

Herzzentrum Leipzig

Leipzig, Germany

Deutsches Herzzentrum Muenchen

München, Germany

Outcomes

Primary Outcomes

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

Time frame: intraprocedural

Secondary Outcomes

Angiographic Success

'Angiographic Success', defined as the achievement of residual angiographic stenosis \<30% of the target lesion in the presence of TIMI 3 flow

Time frame: 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 \[CABG\])

Time frame: 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 \[RA\])

Time frame: intraprocedural

Acute lumen gain,

Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)

Time frame: intraprocedural

Complementary lesion preparations

Number of complementary lesion preparations with further devices (i.e. rotational atherectomy \[RA\])

Time frame: intraprocedural

Rate of vessel perforation

Time frame: intraprocedural

Data from ClinicalTrials.gov

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