Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

Acute Ischemic Stroke Clinical Trial

— PROTECT  

Official title:

Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153655
• Other study ID #: PROTECT
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: January 2023
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Local ischemic post-conditioning
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.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after intervention on the day of ischemic post-conditioning