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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22538

Enrollment

Registered

2020-05-26

Start date

2020-05-26

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Coronary artery disease

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: • 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).

Exclusion criteria

Exclusion criteria: • 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 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.

Design outcomes

Primary

Measure	Time frame
Stent expansion measured by OCT	—

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactThomas Oomens

OLVG

t.oomens@olvg.nl0205994698

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)