Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

NCT ID: NCT05153655

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2022-08-15

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ischemic post-conditioning group

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

Group Type: EXPERIMENTAL

Local ischemic post-conditioning

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27.

Reference Type: DERIVED

PMID: 37497674 (View on PubMed)

Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.

Reference Type: DERIVED

PMID: 36523440 (View on PubMed)

Other Identifiers

PROTECT

Identifier Type: -

Identifier Source: org_study_id