Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06711822

The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification

Led by Keya Medical · Updated on 2024-12-02

205

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .

CONDITIONS

Official Title

The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • Significant coronary artery disease suitable for PCI treatment
  • Single newly developed narrowing in left anterior descending, right coronary, or circumflex artery (or branches) with stenosis degree 70% or 50% with ischemia
  • Target lesion is primary, in situ coronary artery lesion
  • Reference vessel diameter 2.0-4.0 mm and lesion length up to 40 mm
  • Lesion site can allow passage of pre-dilator or trial instrument
  • Moderate to severe calcification at target lesion by angiography or IVUS calcium score 62 points
  • TIMI grade 3 blood flow in target vessel before registration (pre-dilation allowed)
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than 40%
  • NYHA class III or IV heart failure
  • Single coronary artery supply
  • Evidence of dissection at lesion site on imaging
  • Tortuous vascular pathway preventing device passage or retrieval
  • Active systemic infections
  • Uncontrollable severe hypertension (systolic >180 mmHg or diastolic >110 mmHg)
  • Coagulopathy, hypercoagulable state, or significant bleeding tendency (hemoglobin <10 g/dL or platelet count <8010^9/L)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Anzhen Hosipital

Beijing, Beijing Municipality, China, 010

Actively Recruiting

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Research Team

X

XIANTAO SONG, Dortor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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