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RESCUE-ICAS: Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05403593
Collaborator
University of Göttingen (Other), Thomas Jefferson University (Other), University of Miami (Other), University of Basel (Other), University of Tennessee Health Science Center (Other), Wake Forest University Health Sciences (Other), Emory University (Other), The University of Texas Health Science Center at San Antonio (Other), University of Iowa (Other), Indiana University (Other), University of Chicago (Other), Careggi Hospital (Other), Massachusetts General Hospital (Other), Imam Abdulrahman Bin Faisal University (Other), Brown University (Other), Yale University (Other), Sutter Health (Other), Centro Hospitalar de Lisboa Central (Other), HCA Houston Healthcare Kingwood (Other)
600
Enrollment
19
Locations
17.9
Anticipated Duration (Months)
31.6
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Dec 14, 2022
Anticipated Study Completion Date :
Jun 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Participants with Intracranial Stenosis

Patients with Intracranial Stenosis who undergo Mechanical Thrombectomy will be added to the registry given they meet the age inclusion criteria.

Other: No Intervention
No intervention, prospective data collection

Outcome Measures

Primary Outcome Measures

  1. modified Rankin score [pre-stroke]

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  2. modified Rankin score [7 days]

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  3. modified Rankin score [admission]

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  4. modified Rankin score [3 months]

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  5. Mortality [90 day]

    Death at 90 days post intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • All patients undergoing mechanical thrombectomy

  • AND have intracranial stenosis

  • Patients aged 18-90 years

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale New Haven Hospital New Haven Connecticut United States 06508
2 Univeristy of Miami Health System Miami Florida United States 33136
3 Emory Univeristy Hospital Atlanta Georgia United States 30322
4 Univeristy of Chicago Medicine Chicago Illinois United States 60637
5 Advocate Aurora Health Oak Lawn Illinois United States 60453
6 Indiana Health Univeristy Hospital Indianapolis Indiana United States 46202
7 Univeristy of Iowa Hospital Iowa City Iowa United States 52242
8 Massachuestts General Hospital Boston Massachusetts United States 02114
9 Atrium Health Wake Forest Baptist Winston-Salem North Carolina United States 27157
10 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
11 Brown University Providence Rhode Island United States 02903
12 Medical University of South Carolina Charleston South Carolina United States 29425
13 The University of Tennessee Health Science Center Memphis Tennessee United States 38163
14 Univeristy of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
15 Universitätsmedizin Göttingen Göttingen Germany 37099
16 Careggi Universtiy Hospital Florence Italy 50134
17 Nova University Lisbon LIsbon Portugal 1169-056
18 Imam Abdulrahman Alfaisal University Dammam Saudi Arabia 34212
19 Universitätsspital Basel Basel Switzerland 4031

Sponsors and Collaborators

  • Medical University of South Carolina
  • University of Göttingen
  • Thomas Jefferson University
  • University of Miami
  • University of Basel
  • University of Tennessee Health Science Center
  • Wake Forest University Health Sciences
  • Emory University
  • The University of Texas Health Science Center at San Antonio
  • University of Iowa
  • Indiana University
  • University of Chicago
  • Careggi Hospital
  • Massachusetts General Hospital
  • Imam Abdulrahman Bin Faisal University
  • Brown University
  • Yale University
  • Sutter Health
  • Centro Hospitalar de Lisboa Central
  • HCA Houston Healthcare Kingwood

Investigators

  • Principal Investigator: Sami Al Kasab, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sami Al Kasab, MD, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05403593
Other Study ID Numbers:
  • Pro00115854
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sami Al Kasab, MD, MD, Medical University of South Carolina
Intracranial Stenosis
Large Vessel Occlusion
Additional relevant MeSH terms:
Intracranial Arteriosclerosis
Atherosclerosis

Study Results

No Results Posted as of Jun 3, 2022