Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-10-06
Brief Title:
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
Sponsor:
Baim Institute for Clinical Research
Organization:
Baim Institute for Clinical Research
Study Overview
Official Title:
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial Short-Cut
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
None
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?:
None