Registry of Coronary Lithotripsy in Spain. (REPLICA)

Fundación EPIC

Status: Completed

Conditions: Coronary Artery Disease; Arterial Occlusive Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis

Treatments: Other: Intracoronary lithotripsy (ICL)

Study type: Observational

Funder types: Other

Identifiers

NCT04298307

EPIC18-REPLICA

Details and patient eligibility

About

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.

Full description

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.

Enrollment: 426 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age.
• Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an ICL with the Shockwave catheter.
• The patients have been informed of the study characteristics and have given their written informed consent.

Exclusion criteria

• Refusal to participate in this study.
• Patients whose life expectancy is < 1 year.
• Patients with hemodynamic instability with Killip class III or IV.

Trial design

426 participants in 1 patient group

Patients with calcified coronary artery disease

Description:

Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.

Treatment:

Other: Intracoronary lithotripsy (ICL)