ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

About this trial

Last updated 4 months ago

Study ID

3W RCG 1

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 3 months ago

What is this trial about?

Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed. This is a minimally invasive procedure used to treat narrowed or blocked coronary arteries. Sometimes a stent is placed to keep the artery open. If the lesions in the coronary artery are calcified, this may cause difficulties for successful stent placement. The calcified plaques can be fractured via intravascular lithotripsy (IVL) with devices like ShockWave IVL and ShockFast IVL. The aim of this study is to compare the this relatively new ShockFast IVl with the more widely used ShockWave IVL.

What are the participation requirements?

Inclusion Criteria

1. Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing Angiographic criteria:

2. Native de novo coronary lesions

3. Vessel diameter between 2.5mm - 4.0mm

4. Lesion Length: ≤40mm

5. Severe Calcification:

1. Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other

2. Presence of severe calcified protruding noduli

6. No flow disturbances at baseline (Thrombolysis in Myocardial Infarction [TIMI] 3 flow at baseline)

7. Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia OCT Criteria:

8. Total calcium arc > 180° or

9. Presence of a protruding calcified noduli

Exclusion Criteria

1. Ejection fraction less than 25%

2. Lesion located in Left Main (LM) coronary artery

3. Calcifications located mostly > 0.5 mm from the vessel lumen.

4. Severe renal Impairment; Serum Creatinine > 220 μmol or currently undergoing hemodialysis

5. Severe lesion tortuosity where OCT is judged impossible to cross.

6. Inability to tolerate dual antiplatelet therapy for 6 months or longer

7. Inability to obtain inform consent or deemed poorly compliant by the investigator

8. Presence of permanent pacemaker

9. Angiographic evidence of thrombus in the target vessel

10. Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX)

11. Target lesion is a chronic total occlusion (CTO)

12. Presence of aneurysm within 10mm proximal or distal to the target lesion