Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Corona… (NCT06787547) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)
China266 participantsStarted 2021-12-01
Plain-language summary
This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years old
✓. Evidence of asymptomatic ischemia, stable or unstable angina
✓. Patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to undergo angiography, OCT, and clinical follow-up.
✓. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
✓. Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
✓. Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
✓. The lesion allows 0.014 guide wires to pass through
✓. Under multi-angle contrast conditions, it can be seen that there are calcified angiography lesions on both sides of the lesion blood vessel wall (the target lesion meets the definition of severe calcification).
Exclusion criteria
✕. Acute myocardial infarction occurred within 30 days before procedural
✕. Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
✕. Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
✕
What they're measuring
1
Procedural success rate
Timeframe: During hospitalization (up to 7 days after operation)
Trial details
NCT IDNCT06787547
SponsorSpectrumedics Medical Technology(Shanghai)Co.,Ltd