Calcified Coronary Artery Disease (Grade 3) Clinical Trial
— ISAR-CALCOfficial 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
Verified date | November 2019 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)).
Status | Completed |
Enrollment | 74 |
Est. completion date | October 23, 2019 |
Est. primary completion date | September 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Universitäts-Herzzentrum Freiburg Bad Krozingen | Bad Krozingen | |
Germany | Segeberger Kliniken GmbH | Bad Segeberg | |
Germany | Herzzentrum Leipzig | Leipzig | |
Germany | Deutsches Herzzentrum Muenchen | Muenchen | |
Switzerland | Luzerner Kantonsspital | Luzern |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen | SIS Medical AG |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | intraprocedural | |
Secondary | Angiographic Success | 'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow | intraprocedural | |
Secondary | 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]) | 30 days | |
Secondary | 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]) | intraprocedural | |
Secondary | Acute lumen gain, | Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm) | intraprocedural | |
Secondary | Complementary lesion preparations | Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA]) | intraprocedural | |
Secondary | Rate of vessel perforation | Rate of vessel perforation | intraprocedural | |
Secondary | Procedure duration | Procedure duration in min | intraprocedural | |
Secondary | Contrast volume | Contrast volume in mL | intraprocedural |