A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
- Conditions
- Calcified Coronary Artery Disease (Grade 3)
- Interventions
- Device: Super High-Pressure NC PTCA Balloon (OPN NC)Device: Scoring PTCA Balloon (NSE Alpha)
- Registration Number
- NCT03487432
- Lead Sponsor
- Deutsches Herzzentrum Muenchen
- 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)).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPN NC Super High-Pressure NC PTCA Balloon (OPN NC) Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC) NSE Alpha Scoring PTCA Balloon (NSE Alpha) Patients receiving a Scoring PTCA Balloon (NSE Alpha)
- Primary Outcome Measures
Name Time Method Stent expansion index (SEI) intraprocedural Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis
- Secondary Outcome Measures
Name Time Method Rate of vessel perforation intraprocedural Rate of vessel perforation
Procedural Success 30 days '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 \[CABG\])
Complementary lesion preparations intraprocedural Number of complementary lesion preparations with further devices (i.e. rotational atherectomy \[RA\])
Contrast volume intraprocedural Contrast volume in mL
Angiographic Success intraprocedural 'Angiographic Success', defined as the achievement of residual angiographic stenosis \<30% of the target lesion in the presence of TIMI 3 flow
Strategy Success intraprocedural '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 \[RA\])
Acute lumen gain, intraprocedural Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)
Procedure duration intraprocedural Procedure duration in min
Trial Locations
- Locations (5)
Luzerner Kantonsspital
🇨ðŸ‡Luzern, Switzerland
Universitäts-Herzzentrum Freiburg Bad Krozingen
🇩🇪Bad Krozingen, Germany
Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Muenchen, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany