Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03284229
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2017-09-08
Brief Title:
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
Sponsor:
Spectranetics Corporation
Organization:
Spectranetics Corporation
Study Overview
Official Title:
A Prospective Open Label Non-randomized Single-Arm Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in Treatment of Patients With Single or Multivessel Coronary Artery Disease CAD
Status:
COMPLETED
Status Verified Date:
2020-07
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:
ELCA-CAD
Brief Summary:
This is a Prospective Open label Non-randomized Single-Arm Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in Treatment of Patients with Single or Multivessel Coronary Artery Disease CAD Up to 30 patients will be enrolled at up to 05 Indian study sites Patients will be followed from enrollment through 30 days 7 days for the effectiveness and safety endpoints at the study centre
Detailed Description:
Each subject will be followed from enrollment through 30 days 7 days for the effectiveness and safety endpoints Upon enrollment after obtaining a written informed consent each patient will be assigned a unique identification number Only patients eligible to undergo cardiac catheterizations as per routine practice will be considered for the study Premedication of patients will be as per the investigators routine practice All patient data will be recorded on patient data forms
Screening This will be performed prior to the cardiac catheterization procedure Only patients who have consented and fulfill the selection criteria will be enrolled Additionally ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusionexclusion criteria
Procedure The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU
Clinic follow up visit 30 7 days The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification AE assessments concomitant medications and any coronary intervention that has occurred since the previous contact
An electrocardiogram ECG will be repeated during the clinic visit
Screening This will be performed prior to the cardiac catheterization procedure Only patients who have consented and fulfill the selection criteria will be enrolled Additionally ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusionexclusion criteria
Procedure The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU
Clinic follow up visit 30 7 days The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification AE assessments concomitant medications and any coronary intervention that has occurred since the previous contact
An electrocardiogram ECG will be repeated during the clinic visit
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?:
True
Is an FDA AA801 Violation?:
None