Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07010094

BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

Led by BrosMed Medical Co., Ltd · Updated on 2025-07-25

198

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.

CONDITIONS

Official Title

BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years, male or female
  • Evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction
  • Ability and willingness to comply with all study assessments
  • Target lesion is a new, untreated coronary artery lesion
  • Target lesion length of 40 mm or less and reference vessel diameter between 2.0 and 4.0 mm
  • Target lesion diameter stenosis visually estimated at 70% or more, or between 50% and 70% with ischemia evidence
  • Clear high-density calcification visible during cardiac contraction and rest
  • Target vessel TIMI flow grade 3 before using the investigational device
  • Only one calcified lesion treated with shockwave therapy in this session
  • Patients suitable for metal stent implantation
Not Eligible

You will not qualify if you...

  • ST-segment elevation myocardial infarction within 3 days before the procedure
  • Use of rotational atherectomy or special balloons for lesion pretreatment
  • New York Heart Association functional class III or IV
  • Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or PTCA treatment
  • Uncontrolled severe hypertension (systolic >180 mmHg or diastolic >110 mmHg)
  • Severe liver or kidney dysfunction or chronic kidney failure requiring dialysis
  • Platelet count below 60 x 10^9/L
  • Stroke within 6 months before enrollment, excluding TIA and lacunar infarction
  • Active peptic ulcer or recent upper gastrointestinal bleeding within 6 months
  • Known allergies to heparin, contrast agents, aspirin, clopidogrel, or anesthetics
  • Life expectancy under 12 months due to severe medical conditions
  • Previous participation in other trials not meeting primary endpoint
  • Pregnant or breastfeeding women
  • Poor compliance or inability to complete the study
  • Target lesion and non-target lesion in the same vascular branch
  • Target lesion at origin of LAD, LCX, or RCA within 5 mm, or unprotected left main lesion
  • Stent implanted within 10 mm of target lesion ends
  • Target lesion with unprotected branch vessel 2.5 mm or larger
  • Target lesion distal to saphenous vein or mammary artery bypass graft
  • Aneurysm within 10 mm of target lesion
  • NHLBI classification D-F arterial dissection at target lesion before device use
  • Target lesion with definite thrombus formation
  • Investigator's judgment that lesion is unsuitable for vascular dilation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Xiamen University Affiliated Cardiovascular Hospital

Fujian, Xiamen, China, 361000

Actively Recruiting

Loading map...

Research Team

W

Wang Yan, Professor

CONTACT

W

Wang Yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here