Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06089135
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
Sponsor:
Baim Institute for Clinical Research
Organization:
Study Overview
Official Title:
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Short-Cut
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: