Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02240862
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2014-09-12
Brief Title:
The CREST-2 Registry
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The CREST-2 Registry
Status:
RECRUITING
Status Verified Date:
2024-10
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:
C2R
Brief Summary:
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial clinicaltrialsgov ID NCT02089217 Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting CAS performed by experienced and skilled interventionists Interventionists eligibility will be determined by a multi-specialty Interventional Management Committee IMC Patient eligibility will include patients with standard or high-risk symptomatic or asymptomatic carotid artery disease Patients will be followed for the occurrence of post-procedural complications The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial
Detailed Description:
Objectives
1 Promote the rapid initiation and completion of enrollment in CREST-2
2 CAS will be performed by experienced operators
3 Clinical outcomes will be closely monitored
4 Prevent inappropriate use of CAS outside of the registry
Registry Data Collection
The registry will leverage the existing data-collection infrastructure of the Society for Vascular Surgerys SVS Vascular Quality Initiative VQI and the American College of Cardiologys ACC National Cardiovascular Data Registry NCDR Both organizations have agreed to participate in this effort The specific logistics of data-collection and transfer are
The interventionist must pick a registry SVS VQI or ACC NCDR to enter data
The interventionist instructs their registry to transfer de-identified information about their cases to C2R
The cases are reviewed by the C2R Management Committee
Reports of the cases including whether or not they are CREST-2 eligible will be maintained These reports will allow close monitoring of C2R interventionists
C2R Management Committee and other parties NINDS CMS will be informed of the progress periodically
The registry will collect information on key co-morbidities and limit the outcome measures to essential easily used standardized measures that are commonly part of carotid trials including the NIH Stroke Scale and the Modified Rankin Scale mRS The 30-day visit will be conducted face-to-face with a history examination and testing
DEMOGRAPHICS AND MEDICAL HISTORY Gender symptomatic status carotid artery to be treated hypertension diabetes coronary artery disease congestive heart failure and renal failure
MONITORING ENROLLMENT The Registry will also collect information on features that represent inclusionexclusion criteria for the CREST-2 randomized trial The purpose is to facilitate monitoring of the type of patients being enrolled in C2R and ensuring that CREST-2-eligible patients are not being enrolled excessively into C2R in preference to CREST-2 Data- collection transfer and review will occur rapidly enough that sites not complying with enrollment limitations will be identified rapidly and appropriate action taken
PROCEDURAL DETAILS The C2R focuses on procedural details that will facilitate an assessment for credentialing interventionists into the CREST-2 trial The interventional management committee will review this data to make decisions regarding whether or not to approve a particular operator for randomizing patients into the trial Some of the factors to be considered will include
Total number of cases performed per year total number of cases performed in career
Selection of devices case selection stroke rate hemorrhagic complications
Techniques for access sheath placement wire access embolic protection angioplasty stent deployment use of post-stent angioplasty selection of closure devices use of medications antiplatelets anticoagulation atropine nitroglycerine
PATIENT ASSESSMENT AND OUTCOMES NIH Stroke Scale modified Rankin Score access site hemorrhage recurrent hospitalization or need for second carotid procedure new onset of renal failure stroke and death
Eligibility to participate in the C2R
Centers
Any center currently certified by CMS to provide CAS will be eligible to apply for participation in the C2R
Operators
Individual operators must have done at least 50 total procedures to be eligible for the registry If they have done less than 50 procedures then they must have done at least 8 procedures over the last 2 years
Individual operators must have been reviewed and approved by the interventional management committee
The final decision regarding eligibility will also depend on an assessment of technique outcomes and anticipated carotid disease volume at a particular site
Procedures to ensure enrollment into the randomized trial
The maximal enrollment number for C2R for a given site prior to randomization into CREST-2 will be a total of 75 cases or 30 CREST-2 eligible patients whichever comes first
Operators that have been credentialed by the IMC to enroll patients in CREST-2 must begin to enroll eligible patients in the trial while other operators at the same site continue to work toward credentialed status
Sites that have reached the maximum thresholds above and are not initiated as CREST-2 sites will have registry status denied at the discretion of the C2R Management committee depending on bona fide good faith efforts to meet CREST-2 site initiation requirements
The C2R will track whether or not each patient enrolled in the registry was CREST-2 eligible Once any operator at a site has been approved to enroll patients in CREST-2 the site will be expected to offer enrollment into CREST- 2 to every CREST-2 eligible patient It is anticipated that not all such CREST-2 eligible patients will consent to randomization into CREST-2 such patients can be enrolled into the registry However only 1 CREST-2-eligible patient can be enrolled into C2R for each patient enrolled into CREST-2 ie in a 11 ratio
Sites that do not maintain the 11 ratio of patients enrolled in CREST-2 to trial-eligible patients enrolled in C2R will be notified by the C2R Management Committee that they are on a probationary status to remedy the situation If not remedied they will be notified that their C2R status is being revoked
Sites that are not enrolling into CREST-2 at a reasonable rate to be determined by the C2R Management Committee and the CREST-2 Executive Committee will have their eligibility to enroll in the C2R suspended until they are adequately enrolling in the trial
Once the CAS arm of CREST-2 is fully enrolled continued enrollment of eligible patients see inclusionexclusion criteria above in the C2R will be allowed
The DSMB will review CREST-2 trial results at the end of enrollment of the CREST-2 trial to decide at that time if it is ethical to continue C2R
Registry Oversight Governance
The C2R will be operated under a multi-specialty Steering Committee The Steering Committee will include members from relevant disciplines Representatives from the CREST-2 NINDS and CMS will be members of the Steering Committee The Steering Committee shall provide strategic direction to C2R monitor all activities and have ultimate authority and responsibility for the scientific integrity and appropriate use of the C2R data for research and publications Operational responsibilities of the Steering Committee will include oversight of the CAS operatorfacility credentialing process as well as developing and improving other key aspects of registry functions
The Steering Committee will also have the discretion to modify elements of this protocol if such changes are determined to be necessary for the successful implementation of C2R
The Management Committee will carry out day-to-day management and regulatory responsibilities reporting to the Steering Committee Membership will include at least one leader from the surgical stenting and neurological communities The registry Principal Investigator PI will be Brajesh K Lal Co-Principal Investigator of CREST-2
1 Promote the rapid initiation and completion of enrollment in CREST-2
2 CAS will be performed by experienced operators
3 Clinical outcomes will be closely monitored
4 Prevent inappropriate use of CAS outside of the registry
Registry Data Collection
The registry will leverage the existing data-collection infrastructure of the Society for Vascular Surgerys SVS Vascular Quality Initiative VQI and the American College of Cardiologys ACC National Cardiovascular Data Registry NCDR Both organizations have agreed to participate in this effort The specific logistics of data-collection and transfer are
The interventionist must pick a registry SVS VQI or ACC NCDR to enter data
The interventionist instructs their registry to transfer de-identified information about their cases to C2R
The cases are reviewed by the C2R Management Committee
Reports of the cases including whether or not they are CREST-2 eligible will be maintained These reports will allow close monitoring of C2R interventionists
C2R Management Committee and other parties NINDS CMS will be informed of the progress periodically
The registry will collect information on key co-morbidities and limit the outcome measures to essential easily used standardized measures that are commonly part of carotid trials including the NIH Stroke Scale and the Modified Rankin Scale mRS The 30-day visit will be conducted face-to-face with a history examination and testing
DEMOGRAPHICS AND MEDICAL HISTORY Gender symptomatic status carotid artery to be treated hypertension diabetes coronary artery disease congestive heart failure and renal failure
MONITORING ENROLLMENT The Registry will also collect information on features that represent inclusionexclusion criteria for the CREST-2 randomized trial The purpose is to facilitate monitoring of the type of patients being enrolled in C2R and ensuring that CREST-2-eligible patients are not being enrolled excessively into C2R in preference to CREST-2 Data- collection transfer and review will occur rapidly enough that sites not complying with enrollment limitations will be identified rapidly and appropriate action taken
PROCEDURAL DETAILS The C2R focuses on procedural details that will facilitate an assessment for credentialing interventionists into the CREST-2 trial The interventional management committee will review this data to make decisions regarding whether or not to approve a particular operator for randomizing patients into the trial Some of the factors to be considered will include
Total number of cases performed per year total number of cases performed in career
Selection of devices case selection stroke rate hemorrhagic complications
Techniques for access sheath placement wire access embolic protection angioplasty stent deployment use of post-stent angioplasty selection of closure devices use of medications antiplatelets anticoagulation atropine nitroglycerine
PATIENT ASSESSMENT AND OUTCOMES NIH Stroke Scale modified Rankin Score access site hemorrhage recurrent hospitalization or need for second carotid procedure new onset of renal failure stroke and death
Eligibility to participate in the C2R
Centers
Any center currently certified by CMS to provide CAS will be eligible to apply for participation in the C2R
Operators
Individual operators must have done at least 50 total procedures to be eligible for the registry If they have done less than 50 procedures then they must have done at least 8 procedures over the last 2 years
Individual operators must have been reviewed and approved by the interventional management committee
The final decision regarding eligibility will also depend on an assessment of technique outcomes and anticipated carotid disease volume at a particular site
Procedures to ensure enrollment into the randomized trial
The maximal enrollment number for C2R for a given site prior to randomization into CREST-2 will be a total of 75 cases or 30 CREST-2 eligible patients whichever comes first
Operators that have been credentialed by the IMC to enroll patients in CREST-2 must begin to enroll eligible patients in the trial while other operators at the same site continue to work toward credentialed status
Sites that have reached the maximum thresholds above and are not initiated as CREST-2 sites will have registry status denied at the discretion of the C2R Management committee depending on bona fide good faith efforts to meet CREST-2 site initiation requirements
The C2R will track whether or not each patient enrolled in the registry was CREST-2 eligible Once any operator at a site has been approved to enroll patients in CREST-2 the site will be expected to offer enrollment into CREST- 2 to every CREST-2 eligible patient It is anticipated that not all such CREST-2 eligible patients will consent to randomization into CREST-2 such patients can be enrolled into the registry However only 1 CREST-2-eligible patient can be enrolled into C2R for each patient enrolled into CREST-2 ie in a 11 ratio
Sites that do not maintain the 11 ratio of patients enrolled in CREST-2 to trial-eligible patients enrolled in C2R will be notified by the C2R Management Committee that they are on a probationary status to remedy the situation If not remedied they will be notified that their C2R status is being revoked
Sites that are not enrolling into CREST-2 at a reasonable rate to be determined by the C2R Management Committee and the CREST-2 Executive Committee will have their eligibility to enroll in the C2R suspended until they are adequately enrolling in the trial
Once the CAS arm of CREST-2 is fully enrolled continued enrollment of eligible patients see inclusionexclusion criteria above in the C2R will be allowed
The DSMB will review CREST-2 trial results at the end of enrollment of the CREST-2 trial to decide at that time if it is ethical to continue C2R
Registry Oversight Governance
The C2R will be operated under a multi-specialty Steering Committee The Steering Committee will include members from relevant disciplines Representatives from the CREST-2 NINDS and CMS will be members of the Steering Committee The Steering Committee shall provide strategic direction to C2R monitor all activities and have ultimate authority and responsibility for the scientific integrity and appropriate use of the C2R data for research and publications Operational responsibilities of the Steering Committee will include oversight of the CAS operatorfacility credentialing process as well as developing and improving other key aspects of registry functions
The Steering Committee will also have the discretion to modify elements of this protocol if such changes are determined to be necessary for the successful implementation of C2R
The Management Committee will carry out day-to-day management and regulatory responsibilities reporting to the Steering Committee Membership will include at least one leader from the surgical stenting and neurological communities The registry Principal Investigator PI will be Brajesh K Lal Co-Principal Investigator of CREST-2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None