NL-OMON49291
Recruiting
Phase 4
EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries - EXIT-CALC
OLVG0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary atherosclerosis
- Sponsor
- OLVG
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\= 18 years
- •2\. An indication for PCI of a calcified lesion in an native coronary artery
- •3\. 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
- •4\. Written informed consent with agreement of follow\-up visits.
- •5\. Eligible for PCI with a target vessel reference diameter between 2\.5 and 4\.0
- •mm (by visual estimation).
Exclusion Criteria
- •1\. Severe congestive heart failure, severe heart failure NYHA IV
- •2\. ST\-elevation myocardial infarction as indication for PCI
- •3\. Severe renal impairment with a glomerular filtration rate of \<30ml/min/1\.73m2
- •4\. Lesion related exclusion criteria
- •5\. Stent occlusion / restenosis
- •6\. OCT images not fulfilling inclusion criteria
- •7\. Inability to cross the lesion with an OCT catheter
- •8\. Large side branch (\>2\.0mm) originating from the target lesion
- •9\. Contraindication for dual antiplatelet therapy.
- •10\. Recent history of major bleeding, hematologic disease and/or platelet count
Outcomes
Primary Outcomes
Not specified
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