Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07093788

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-03-10

78

Participants Needed

3

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

CONDITIONS

Official Title

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years and < 80 years
  • Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI)
  • Have an indication for drug-eluting stent (DES) implantation
  • Denovo coronary artery calcified lesions
  • Target lesion diameter stenosis  70%, or target lesion diameter stenosis between  50% and < 70% accompanied by evidence of myocardial ischemia such as fractional flow reserve (FFR)  0.80 or minimal lumen area (MLA)  4.0 mm8
  • Reference vessel diameter of target vessel between 2.5 mm and 4.5 mm
  • Maximum calcium arc within the lesion  2706 assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
  • Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of < 30% under maximal inflation pressure
  • Provision of written informed consent
Not Eligible

You will not qualify if you...

  • Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock or multiple organ failure
  • Severe contrast agent allergy
  • Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
  • Active phase of autoimmune disease
  • Calcified nodules or eccentric calcification lesions
  • Failure to reach the target lesion with guidewires or catheters
  • Complex coronary bifurcation lesions
  • Target vessel thrombosis or aneurysm within 10 mm of the target lesion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China, 222000

Actively Recruiting

2

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006

Actively Recruiting

3

Yixing People's Hospital

Yixing, Jiangsu, China, 214200

Actively Recruiting

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Research Team

F

Fei Ye, MD

CONTACT

Y

Yi-fei Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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