EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries

Phase 4

Recruiting

Conditions: Coronary atherosclerosis
heart artery calcification
10011082
10003184
10003216

Registration Number: NL-OMON49291

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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
< 100.000 per 1 mm3
11. Planned major surgery within 3 months after the procedure.
12. Participation in another clinical study, interfering with this protocol.
13. The inability to provide written informed consent.
14. Expected life expectancy of less than two years.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Stent expansion measured by OCT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Periprocedural and in-hospital complications<br /><br>a. Coronary dissection type D-F,<br /><br>b. Coronary perforation,<br /><br>c. Periprocedural infarction (Troponin T rise of >5 times ULN, or a 20%<br /><br>increase if already elevated but stable or falling); assessment if indicated<br /><br>2. MACE at 1 month, 1- and 2-year FU, comprised of death, myocardial<br /><br>infarction, or target-lesion revascularization and each of its individual<br /><br>components<br /><br>3. Stent thrombosis according the ARC criteria: defined as<br /><br>a. Definite or confirmed stent thrombosis: Angiographic confirmation of vessel<br /><br>occlusion or thrombus formation within, or adjacent to, the stented segment or<br /><br>proven stent thrombosis at autopsy.<br /><br>b. Probable stent thrombosis: Unexplained death within 30 days or target vessel<br /><br>recurrent MI without angiographic confirmation.<br /><br>c. Possible stent thrombosis: Unexplained death after 30 days.</p><br>