Intravascular Lithotripsy Catheter Balloon for Calcified Coronary Artery Pilot Study

Not Applicable

Completed

• Conditions: Calcified coronary artery; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12621000697886
• Lead Sponsor: Mackay Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Study Completion: 2021-12-14
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
•The target vessel must have a TIMI flow 3 at baseline
•Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
•Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
•Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery > 50% in a reference vessel of 2.5mm – 4.0 mm diameter and < 32 mm length
•Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
•Planned treatment of single lesion in one vessel
•Ability to pass a 0.014’’ guide wire across the lesion
•Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
•Patient is able and willing to comply with all assessments in the study

Exclusion Criteria

•Concomitant use of other techniques to deal CAC such as atherectomy and special balloons
•Severe renal failure
•Severe anaemia
•Previous PCI within 30 days of planned procedure
•Patients not suitable for consenting such as severe memory impairment
•Acute coronary syndrome within 1 month from planned procedure
•Severe Heart Failure (NYHA III or IV)
•Unable to tolerate dual antiplatelet agents (Aspirin + clopidogrel or ticargrelor or prasugrel) for 1 year for any reason
•Contrast allergy
•Active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified