Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03328949
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2017-10-27
Brief Title:
Shockwave Coronary Lithoplasty Study Disrupt CAD II
Sponsor:
Shockwave Medical Inc
Organization:
Shockwave Medical Inc
Study Overview
Official Title:
Prospective Multi-Center Single Arm Post-Market Study PMS of the Shockwave Medical Inc Coronary Lithoplasty System in Coronary Arteries
Status:
COMPLETED
Status Verified Date:
2019-11
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:
None
Brief Summary:
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent
Detailed Description:
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure
Patients 18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main or left anterior descending right coronary artery or left circumflex will be eligible to enroll in the study The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1 cardiac related death 2 heart attack and 3 intervention to treat the coronary artery that was previously treated at the procedure visit
Patients 18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main or left anterior descending right coronary artery or left circumflex will be eligible to enroll in the study The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1 cardiac related death 2 heart attack and 3 intervention to treat the coronary artery that was previously treated at the procedure visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None