Trials / Completed
CompletedNCT06089135
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 413 (actual)
- Sponsor
- Baim Institute for Clinical Research · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The trial will be composed of two cohorts: * Patients treated with up-front rotational atherectomy * Patients in whom atherectomy is not planned Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts: * After rotational atherectomy is safely completed In the rotational atherectomy arm * After safe and successful wire crossing in patients in whom atherectomy is not planned. The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-12-31
- Primary completion
- 2025-08-30
- Completion
- 2025-09-30
- First posted
- 2023-10-18
- Last updated
- 2026-01-23
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06089135. Inclusion in this directory is not an endorsement.