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A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-CTP)

Primary Purpose

Stroke, Ischemic, Stroke, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NCCT
CTP
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Presenting with acute ischemic stroke with symptoms
  2. Six hours or more from last known well to randomization
  3. Occlusion of the intracranial internal carotid artery, the first or second segment of the middle cerebral artery (MCA-M1 or -M2) confirmed by CTA
  4. Planned treatment with endovascular treatment by clinical care team
  5. Informed consent obtained from patients or their legal representatives

Exclusion Criteria:

  1. CT or MR evidence of hemorrhage;
  2. Pre-stroke baseline mRS scores of 3 to 5
  3. Posterior large vessel occlusion
  4. Currently pregnant or lactating (women patients);
  5. Allergy to radiographic contrast agents, or nitinol devices;
  6. Any terminal illness with life expectancy less than 6 months;
  7. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
  8. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
  9. Unlikely to be available for 90-day follow-up.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Yijishan Hospital of Wannan Medical College
  • Banan District People's Hospital
  • Xinqiao Hospital of Army Medical University
  • Wuyi Traditional Chinese Medicine Hospital
  • Jiangmen Central Hospital
  • Maoming Traditional Chinese Medicine Hospital
  • The 924th Hospital of CPLA
  • Danzhai People's Hospital
  • Nanyang Central Hospital
  • Wuhan No. 1 Hospital
  • The 904th Hospital of CPLA
  • Xuzhou Central Hospital
  • The First Affiliated Hospital of Jilin University
  • The Affiliated Hospital of Southwest Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NCCT

CTP

Arm Description

NCCT and CTA will be used to screen patients for endovascular treatment

NCCT, CTA, and CTP will be used to screen patients for endovascular treatment

Outcomes

Primary Outcome Measures

functional independence at 90 days
defined as modified Rankin scale score of 0 to 2 (handle daily activities without assistance)

Secondary Outcome Measures

symptomatic intracranial hemorrhage within 48 hours
symptomatic intracranial hemorrhage according to Heidelberg criteria
mortality at 90 days
defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period

Full Information

First Posted
January 27, 2022
Last Updated
February 3, 2023
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT05230914
Brief Title
A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-CTP)
Official Title
NOn-contrast Computed Tomography Versus Computed Tomography Perfusion Selection in Stroke Patients for Endovascular Treatment: the NO-CTP Cluster-randomized, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Several studies suggest that advanced multi-modal imaging with CTP should be used to screen late time window stroke patients for thrombectomy. However, NCCT is more accessible when comparing with CTP. It is unclear whether the NCCT-based ASPECTS can be used as an imaging criterion to screen patients for thrombectomy. The aim of this trial was to assess the clinical outcomes of stroke patients with anterior large vessel occlusion presenting in the late time window who selected by NCCT comparing via CTP. The hypothesis is that NCCT is non-inferior to CTP selection in terms of achieving functional independence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke, Acute
Keywords
endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NCCT
Arm Type
Experimental
Arm Description
NCCT and CTA will be used to screen patients for endovascular treatment
Arm Title
CTP
Arm Type
Active Comparator
Arm Description
NCCT, CTA, and CTP will be used to screen patients for endovascular treatment
Intervention Type
Other
Intervention Name(s)
NCCT
Intervention Description
NCCT and CTA will be used to screen patients for endovascular treatment
Intervention Type
Other
Intervention Name(s)
CTP
Intervention Description
NCCT, CTA, and CTP will be used to screen patients for endovascular treatment
Primary Outcome Measure Information:
Title
functional independence at 90 days
Description
defined as modified Rankin scale score of 0 to 2 (handle daily activities without assistance)
Time Frame
90 days post-endovascular treatment
Secondary Outcome Measure Information:
Title
symptomatic intracranial hemorrhage within 48 hours
Description
symptomatic intracranial hemorrhage according to Heidelberg criteria
Time Frame
within 48 hours post-endovascular treatment
Title
mortality at 90 days
Description
defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period
Time Frame
90 days post-endovascular treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting with acute ischemic stroke with symptoms Six hours or more from last known well to randomization Occlusion of the intracranial internal carotid artery, the first or second segment of the middle cerebral artery (MCA-M1 or -M2) confirmed by CTA Planned treatment with endovascular treatment by clinical care team Informed consent obtained from patients or their legal representatives Exclusion Criteria: CT or MR evidence of hemorrhage; Pre-stroke baseline mRS scores of 3 to 5 Posterior large vessel occlusion Currently pregnant or lactating (women patients); Allergy to radiographic contrast agents, or nitinol devices; Any terminal illness with life expectancy less than 6 months; Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; Unlikely to be available for 90-day follow-up.
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Yijishan Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241000
Country
China
Facility Name
Banan District People's Hospital
City
Banan
State/Province
Chongqing
ZIP/Postal Code
400040
Country
China
Facility Name
Xinqiao Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Wuyi Traditional Chinese Medicine Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Facility Name
Maoming Traditional Chinese Medicine Hospital
City
Maoming
State/Province
Guangdong
ZIP/Postal Code
525000
Country
China
Facility Name
The 924th Hospital of CPLA
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Facility Name
Danzhai People's Hospital
City
Danzhai
State/Province
Guizhou
ZIP/Postal Code
557500
Country
China
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Wuhan No. 1 Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The 904th Hospital of CPLA
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study data without patient information
IPD Sharing Time Frame
Related papers published 6 months later, the IPD will be shared
IPD Sharing Access Criteria
yangqwmlys@163.com ziwenjie1981@163.com

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A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-CTP)

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