NCT07835178

Brief Summary

This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
26mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Dec 2028

Study Start

First participant enrolled

September 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Coronary Artery DiseaseCalcification

Keywords

Coronary artery diseasecalcification lesion

Outcome Measures

Primary Outcomes (1)

  • Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation

    IVUS-measured results obtained after stent implantation and prior to balloon post-dilation

    procedure day (0 day)

Secondary Outcomes (3)

  • Procedural success

    procedure day (0 day)

  • Strategy success

    procedure day (0 day)

  • Major adverse cardiac events (MACE)

    the hospitalization period and 30-day after procedure

Study Arms (2)

Test group

EXPERIMENTAL

In the test group, the lesion is prepared using a high-pressure cutting balloon prior to DES implantation.

Device: High pressure cutting balloon

Control group

EXPERIMENTAL

In the control group, the lesion is prepared using a non-cutting balloon prior to DES implantation.

Device: Non-cutting balloon

Interventions

High pressure cutting balloonDEVICE

Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.

Test group
Non-cutting balloonDEVICE

Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
  • Moderate-to-severe calcified lesions on coronary angiography;
  • Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
  • Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
  • In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
  • Provision of written informed consent.

You may not qualify if:

  • Life expectancy \<1 year;
  • Cardiogenic shock or hemodynamic instability;
  • Left main coronary artery disease;
  • Chronic total occlusion;
  • Bifurcation lesions planned for a "two-stent strategy";
  • Active bleeding;
  • Known history of allergy to contrast media or metals;
  • Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
  • New-onset stroke/transient ischemic attack within 6 months;
  • Pregnant or lactating women;
  • Left ventricular ejection fraction \<25%, or NYHA functional class IV, or Killip class ≥2;
  • Non-target vessel revascularization within 30 days before randomization with complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCalcinosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Ning Guo, Professor

CONTACT

85323473hearthx@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 22, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)