Lithotripsy vs Cutting Balloon for Coronary Artery Disease

(Short-Cut Trial)

Recruiting at 21 trial locations

Overseen By Ajay Kirtane, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baim Institute for Clinical Research

Disqualifiers: Pregnancy, LVEF < 25%, STEMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Index procedure

410 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cutting Balloon and Intravascular Lithotripsy for Coronary Artery Disease?

Research shows that intravascular lithotripsy (IVL) is effective for treating calcified coronary arteries, and it can be a good option when other methods don't work well. Studies comparing IVL to other treatments like modified balloon angioplasty and rotational atherectomy suggest that IVL is a promising new technology for preparing blocked arteries. ^{1 2 3 4 5}

Is intravascular lithotripsy safe for treating coronary artery disease?

Intravascular lithotripsy (IVL) is generally considered safe for treating calcified coronary arteries, but as its use increases, some complications have been reported. Most studies show it is effective and safe, though rare complications like artery dissection have occurred. ^{1 3 4 6 7}

How does the treatment of lithotripsy and cutting balloon differ from other treatments for coronary artery disease?

Intravascular lithotripsy is unique because it uses high-pressure ultrasonic energy to break down calcified plaque in coronary arteries, making it a novel tool for treating severe calcification. Cutting balloons, on the other hand, have small blades that make precise cuts in the artery to help open blockages, which can be more effective for certain types of calcified lesions compared to conventional balloons. ^{2 8 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 21 with moderate to severely calcified coronary arteries, who have a stenosis of more than 50% but less than 70%, and show signs of ischemia. They must need PCI treatment for conditions like stable coronary artery disease, unstable angina, or NSTEMI with decreasing biomarkers.

Inclusion Criteria

You are at least 21 years old, have a cardiac condition for which percutaneous coronary intervention is recommended (stable coronary artery disease, unstable angina or NSTEMI with decreasing biomarkers) and you give your informed consent to participate in the study.

You have either more than 270 degrees of superficial calcium on intravascular imaging with a length greater than 5mm, or complete circumferential coverage by 360 degrees.

I have a partially blocked artery confirmed by a test showing reduced blood flow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either cutting balloon angioplasty or intravascular lithotripsy, with or without rotational atherectomy, followed by drug-eluting stent implantation

Index procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of post-procedural stent area and MACCE at 30 days

30 days

Treatment Details

Interventions

• Cutting Balloon
• Intravascular Lithotripsy

Trial Overview The Short-Cut trial compares two treatments on patients before they get drug-eluting stents: cutting balloon angioplasty and intravascular lithotripsy. It's a randomized controlled study to see which method works better at treating calcified coronary arteries.

Participant Groups

Group I: Cutting Balloon Active Control 1 Intervention

Group II: Intravascular Lithotripsy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Baim Institute for Clinical Research

Lead Sponsor

Trials

29

Recruited

55,700+

Kathleen Kearney, MD

Collaborator

Trials

1

Recruited

410+

Robert W. Yeh, MD

Collaborator

Trials

1

Recruited

410+

Akiko Maehara, MD

Collaborator

Trials

2

Recruited

460+

Ajay Kirtane, MD

Collaborator

Trials

1

Recruited

410+

C. Michael Gibson, MS, MD

Collaborator

Trials

1

Recruited

410+

Suzanne Baron, MD

Collaborator

Trials

1

Recruited

410+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Coronary Intravascular Lithotripsy Versus Rotational Atherectomy in an Asian Population: Clinical Outcomes in Real-World Patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Bail-out intravascular lithotripsy for severe stent underexpansion during primary angioplasty: a case report. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Propensity-score-matched comparison of safety, efficacy, and outcome of intravascular lithotripsy versus high-pressure PTCA in coronary calcified lesions. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Comparative study of costs and resource utilization of rotational atherectomy versus intravascular lithotripsy for percutaneous coronary intervention. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Type E coronary artery dissection caused by intravascular lithotripsy balloon rupture; vessel anatomy and characteristics in a lithoplasty complication case as detailed by optical coherence tomography: a case report. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Real-world outcomes in treatment of highly calcified coronary lesions with intravascular shockwave lithotripsy. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Coronary angioplasty with controlled longitudinal dissection. Initial clinical results using a new cutting balloon]. [2010]

9. England pubmed.ncbi.nlm.nih.gov

Clinical cases illustrating the efficacy of intra-coronary lithotripsy. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Intracoronary Lithotripsy for the Treatment of Calcified Plaque. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

Cutting balloons versus conventional balloons for treating patients with coronary artery disease presenting with moderate-to-severely calcified lesions: impact on post-interventional minimum stent area. [2022]