A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-10-23

Brief Summary

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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)).

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Detailed Description

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Conditions

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Calcified Coronary Artery Disease (Grade 3)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OPN NC

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

Group Type EXPERIMENTAL

Super High-Pressure NC PTCA Balloon (OPN NC)

Intervention Type DEVICE

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

NSE Alpha

Patients receiving a Scoring PTCA Balloon (NSE Alpha)

Group Type EXPERIMENTAL

Scoring PTCA Balloon (NSE Alpha)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Scoring PTCA Balloon (NSE Alpha)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No