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Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT)

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Local ischemic post-conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years;
  • Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
  • Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
  • Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

  • Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
  • Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
  • Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
  • > 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
  • Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
  • Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.

Sites / Locations

  • Tianjin Huanhu Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ischemic post-conditioning group

Arm Description

The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.

Outcomes

Primary Outcome Measures

Number of participants with major response
Major response is any of the following: Vessel perforation or rupture; Reocclusion of the culprit vessel after post-conditioning; Vessel dissection; Severe vasospasm; Ischemic post-conditioning related thrombotic events; Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
January 2, 2023
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05153655
Brief Title
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy
Acronym
PROTECT
Official Title
Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

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
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic post-conditioning group
Arm Type
Experimental
Arm Description
The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.
Intervention Type
Procedure
Intervention Name(s)
Local ischemic post-conditioning
Intervention Description
Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.
Primary Outcome Measure Information:
Title
Number of participants with major response
Description
Major response is any of the following: Vessel perforation or rupture; Reocclusion of the culprit vessel after post-conditioning; Vessel dissection; Severe vasospasm; Ischemic post-conditioning related thrombotic events; Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.
Time Frame
Immediately after intervention on the day of ischemic post-conditioning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years; Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion; Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography; Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia; Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures; > 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures; Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization; Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.
Facility Information:
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

Learn more about this trial

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

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