Clinical trial NCT03487432: A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcified Coronary Artery Disease (Grade 3)
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: SIS Medical AG
First posted: 2018-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)).


Eligibility criteria: 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.

Primary outcomes:
measure: Stent expansion index (SEI)
timeFrame: intraprocedural
Secondary outcomes:
measure: Angiographic Success
timeFrame: intraprocedural
measure: Procedural Success
timeFrame: 30 days
measure: Strategy Success
timeFrame: intraprocedural
measure: Acute lumen gain,
timeFrame: intraprocedural
measure: Complementary lesion preparations
timeFrame: intraprocedural
measure: Rate of vessel perforation
timeFrame: intraprocedural
measure: Procedure duration
timeFrame: intraprocedural
measure: Contrast volume
timeFrame: intraprocedural
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Robert A Byrne, MD BCh PhD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Salvatore Cassese, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: