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Comparing two treatments for calcified coronary disease

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

Not applicable Interventional Baim Institute for Clinical Research · NCT06089135

This study is testing whether a new balloon treatment works just as well as a special type of ultrasound treatment for people with hardening arteries before they get a stent.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment410 (estimated)
Ages21 Years and up
SexAll
SponsorBaim Institute for Clinical Research Academic / other
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT06089135 on ClinicalTrials.gov

What this trial studies

The Short-Cut trial is a multicenter, randomized controlled trial aimed at comparing the effectiveness of cutting balloon angioplasty and intravascular lithotripsy in patients with moderate to severely calcified coronary arteries. Participants will be randomized into two cohorts: those who have undergone rotational atherectomy and those who have not. The primary goal is to demonstrate non-inferiority between the two treatment methods regarding the post-procedural stent area as assessed by intravascular imaging. This trial seeks to provide insights into the best approach for treating calcified coronary lesions prior to drug-eluting stent implantation.

Who should consider this trial

Good fit: Ideal candidates include adults over 21 with moderate to severe calcification in coronary arteries requiring percutaneous coronary intervention.

Not a fit: Patients with non-calcified coronary lesions or those not requiring PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with calcified coronary disease, potentially enhancing procedural outcomes.

How similar studies have performed: Previous studies have shown promising results with similar approaches, but this trial aims to provide more definitive comparisons between the two techniques.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 1. Subject is \> 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria

  1. The target lesion is a de novo native coronary lesion
  2. The target vessel is a native coronary artery with either:

     1. A stenosis \> 70%; or,
     2. A stenosis \> 50% and \<70% with evidence of ischemia via either positive stress test, FFR value \< 0.80 or RFR/iFR/DFR value \< 0.89
  3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
  4. The target lesion has evidence of significant calcium at the lesion site defined either as,

     1. The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography
     2. the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium

        Exclusion Criteria:

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  1. Patient is pregnant
  2. Patient is actively participating in another clinical trial
  3. Known LVEF \< 25%
  4. Ongoing Non-STEMI with rising biomarkers
  5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
  6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
  7. Patient has a known allergy to contrast which cannot be adequately pre-treated
  8. Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
  9. Patient presents with STEMI
  10. Patient is unable to tolerate dual anti-platelet therapy
  11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days

      Angiographic Exclusion Criteria

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  1. Presence of large thrombus in the target vessel
  2. Inability to pass coronary guidewire across the lesion
  3. The target vessel has excessive tortuosity (Defined as presence of 2+ bends \> 90o or 3+ bends \> 75o) or other anatomic considerations that precludes intravascular imaging
  4. The target lesion is within a coronary artery bypass graft
  5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
  6. Coronary artery disease that requires surgical revascularization
  7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization
  8. Investigator feels there is not equipoise regarding the treatment strategy

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Treatment in Calcified Coronary DiseaseIntravascular LithoplastyCutting BalloonCalcified Coronary DiseasePercutaneous Coronary Intervention
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.