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

C

Capital Medical University

Status

Completed

Conditions

Acute Ischemic Stroke

Treatments

Procedure: Local ischemic post-conditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT05153655
PROTECT

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Ischemic post-conditioning group
Experimental group
Description:
The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.
Treatment:
Procedure: Local ischemic post-conditioning

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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