BASIL Study: A randomised comparison study on the treatment of calcified (hard and concrete-like) coronary artery using the conventional balloon angioplasty prior stenting versus the use of Shockwave Intravascular Lithotripsy (S-IVL) prior to stenting.

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Calcified Coronary Arteries; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Vascular Diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620000086965
• Lead Sponsor: Shockwave Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-03
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients undergoing coronary angiography who is found to have significant calcified coronary stenosis are eligible. Coronary artery stenosis is defined by either qualitative or quantitative coronary angiography with more than 60% diameter stenosis in equal or greater than 2.5 mm reference vessel diameter of coronary artery with severe calcification.

Assessment by intravascular ultrasound (IVUS) with presence of greater than 270° arc of calcification at worst point in lesion. If IVUS cannot be delivered, inclusion can be made by angiographic appearance of heavy calcification.

Exclusion Criteria

• Participant is currently enrolled in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

• Participant is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential).

• Participant experienced an acute ST Elevation Myocardial Infarction (STEMI).

• Patient has contraindication to taking dual antiplatelet therapy for a minimum of 6 months.

• Patients in cardiogenic shock.

• Concomitant use of other calcium modification devices prior to randomisation i.e atherectomy, cutting balloons etc.

• Chronic total occlusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified