EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries
- Conditions
- Coronary artery disease
- Registration Number
- NL-OMON22538
- Lead Sponsor
- .A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
• Age = 18 years
• An indication for PCI of a calcified lesion in a native coronary artery
• Main OCT criterium is a calcification score of 4 defined as maximum calcium angle of >180 degrees, maximum calcium thickness >0.5mm, and a minimal calcium length of 5mm, as measured at the target lesion
• Written informed consent with agreement of follow-up visits.
• Eligible for PCI with a target vessel reference diameter between 2.5 and 4.0 mm (by visual estimation).
• Severe congestive heart failure, severe heart failure NYHA IV
• ST-elevation myocardial infarction as indication for PCI
• Severe renal impairment with a glomerular filtration rate of <30ml/min/1.73m2
• Lesion related exclusion criteria
• Stent occlusion / restenosis
• OCT images not fulfilling inclusion criteria
• Inability to cross the lesion with an OCT catheter
• Large side branch (>2.0mm) originating from the target lesion
• Contraindication for dual antiplatelet therapy.
• Recent history of major bleeding, hematologic disease and/or platelet count < 100.000 per 1 mm3
• Planned major surgery within 3 months after the procedure.
• Participation in another clinical study, interfering with this protocol.
• The inability to provide written informed consent.
• Expected life expectancy of less than two years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent expansion measured by OCT
- Secondary Outcome Measures
Name Time Method • Periprocedural and in-hospital complications<br>- Coronarydissectiontype D-F,<br>- Coronaryperforation,<br>- Periprocedural infarction (Troponin T rise of >5 times ULN, or a 20% increase if already elevated but stable or falling); assessment if indicated<br>• MACE at 1 month, 1- and 2-year FU, comprised of death, myocardial infarction, or target-lesion revascularization and each of its individual components<br>• Stentthrombosis according the ARC criteria: defined as<br>- Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.<br>- Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.<br>- Possible stent thrombosis: Unexplained death after 30 days.