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The CREST-2 Registry (C2R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by University of Maryland
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Centers for Medicare and Medicaid Services
Mayo Clinic
Society for Vascular Surgery
American College of Cardiology
Information provided by (Responsible Party):
Brajesh Lal, University of Maryland
ClinicalTrials.gov Identifier:
NCT02240862
First received: September 12, 2014
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov 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.

Condition Intervention
Carotid Artery Diseases
Device: Carotid Artery Stent

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The CREST-2 Registry

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Any stroke or death within 30 days after the stenting procedure. [ Time Frame: 30 days ]

Estimated Enrollment: 4000
Study Start Date: February 2015
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carotid Artery Disease
Patients undergoing carotid artery stenting for high grade carotid artery stenosis with or without neurologic symptoms and with or without a high risk for carotid endarterectomy.
Device: Carotid Artery Stent
Placement of a stent within the carotid artery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 - 80 years old with symptomatic or asymptomatic carotid artery disease.
Criteria

Inclusion Criteria

Asymptomatic patients:

Age ≥ 18 and ≤ 80 and any one of the following

  1. ≥70% stenosis, standard surgical risk for CEA
  2. ≥70% stenosis, high anatomic risk for CEA
  3. ≥70% stenosis, high physiologic risk for CEA

Symptomatic patients:

Symptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 2; and Ipsilateral transient monocular blindness: amaurosis fugax. [Source: current Medicare NCD for CAS]

Age ≥ 18 and ≤ 80 and any one of the following

  1. ≥50% stenosis, standard surgical risk for CEA
  2. ≥50% to 69% stenosis, high anatomic risk for CEA
  3. ≥70% stenosis, high anatomic and/or physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
  4. ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
  5. ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R

Exclusion Criteria:

Patients with any one of the following conditions are ineligible for enrollment in C2R

  1. NYHA Class IV CHF
  2. COPD on chronic continuous oxygen therapy
  3. Severe (Class Childs D) liver failure
  4. End-stage renal failure requiring dialysis
  5. Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
  6. Any dementia considered greater than "mild"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02240862

Contacts
Contact: Kimberlly A Nordstrom, CCRC 410-706-3941 knordstrom@som.umaryland.edu

Locations
United States, Maryland
University of Maryland - Administrative Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kimberlly A Nordstrom, CCRC    410-706-3941    knordstrom@som.umaryland.edu   
Principal Investigator: Brajesh K Lal, MD         
Sponsors and Collaborators
University of Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Centers for Medicare and Medicaid Services
Mayo Clinic
Society for Vascular Surgery
American College of Cardiology
Investigators
Principal Investigator: Brajesh K Lal, MD University of Maryland
  More Information

Responsible Party: Brajesh Lal, PI, University of Maryland
ClinicalTrials.gov Identifier: NCT02240862     History of Changes
Other Study ID Numbers: HP-00063876
Study First Received: September 12, 2014
Last Updated: April 13, 2017

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2017