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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49291

Enrollment

Registered

2020-04-15

Start date

2020-06-11

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerosis heart artery calcification

Interventions

IVL or balloon dilatation, followed by stenting with DES in all patients

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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 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

Design outcomes

Primary

Measure	Time frame
Stent expansion measured by OCT	—

Secondary

Measure	Time frame
1. Periprocedural and in-hospital complications a. Coronary dissection type D-F, b. Coronary perforation, c. Periprocedural infarction (Troponin T rise of >5 times ULN, or a 20% increase if already elevated but stable or falling); assessment if indicated 2. MACE at 1 month, 1- and 2-year FU, comprised of death, myocardial infarction, or target-lesion revascularization and each of its individual components 3. Stent thrombosis according the ARC criteria: defined as a. 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. b. Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation. c. Possible stent thrombosis: Unexplained death after 30 days.	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)