Atherectomy Devices and intravascUlAr Lithotripsy

Phase 4

Recruiting

• Conditions: ischemic heart disease; Calcified lesion, atherectomy, intravascular lithotripsy

• Registration Number: JPRN-jRCT1032230384
• Lead Sponsor: akamura Masato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.More than 18 years of age
2.Patients with heavily calcified lesions* for which treatment with the IVL System in combination with other atherectomy devices is deemed desirable based on angiographic findings or clinical determination.

Exclusion Criteria

1. Patients on follow-up from this study, or who are participating/may participate in another clinical study that may affect the results of this study.
2. Patients who are ineligible for treatment with the investigational device

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>The primary safety endpoint is to evaluate freedom rate from major adverse cardiac events (MACE) within 30 days of the index study procedure. MACE is defined as the composite occurrence of:<br>-cardiac death<br>myocardial Infarction (MI): MI within 48 hours after procedure, as defined by the Society for Cardiovascular Angiography and Interventions (SCAI), and spontaneous MI after 48 hours, as defined by the Fourth Universal Definition of Myocardial Infarction.<br>-revascularization of target vessels (TVR) (including target lesions)<br>The independent Clinical Evaluation Committee will determine all possible MACE events.<br>Efficacy<br>The primary efficacy endpoint is procedural success defined by less than 50% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE.