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Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

NCT06089135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2026-01-23

No results posted yet for this study

Summary

The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

Conditions

  • Treatment in Calcified Coronary Disease

Interventions

DEVICE

Intravascular Lithotripsy

Intravascular lithotripsy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

DEVICE

Cutting Balloon

Cutting Balloon therapy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

Sponsors & Collaborators

  • Robert W. Yeh, MD

    collaborator UNKNOWN

  • Ajay Kirtane, MD

    collaborator UNKNOWN

  • C. Michael Gibson, MS, MD

    collaborator UNKNOWN

  • Kathleen Kearney, MD

    collaborator UNKNOWN

  • Akiko Maehara, MD

    collaborator UNKNOWN

  • Suzanne Baron, MD

    collaborator UNKNOWN

  • Baim Institute for Clinical Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-08-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

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 NCT06089135 on ClinicalTrials.gov