Calcified Coronary Artery Disease (Grade 3)
Conditions
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)).
Interventions
DEVICESuper 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.
DEVICEScoring PTCA Balloon (NSE Alpha)
Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
Sponsors
SIS Medical AG
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[CABG\]) |
| 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) |
| 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 |
| Rate of vessel perforation | intraprocedural | Rate of vessel perforation |
| Procedure duration | intraprocedural | Procedure duration in min |
| Contrast volume | intraprocedural | Contrast volume in mL |
| Complementary lesion preparations | intraprocedural | Number of complementary lesion preparations with further devices (i.e. rotational atherectomy \[RA\]) |
Countries
Germany, Switzerland
Outcome results
None listed