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

NCT07093788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-10

No results posted yet for this study

Summary

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

  • PCI
  • Coronary Arterial Disease (CAD)
  • Calcified Coronary Lesions

Interventions

DEVICE

super high-pressure balloon

preparation strategy for calcified lesions after unsatisfactory dilation

DEVICE

intravascular lithotripsy (IVL)

preparation strategy for calcified lesions after unsatisfactory dilation

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Fei Ye, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093788 on ClinicalTrials.gov