Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT06089135
Brief 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.
Study:
NCT06089135
Study Brief:
Protocol Section:
NCT06089135