Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Study Details
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 investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ischemic post-conditioning group Mechanical thrombectomy combined with ischemic post-conditioning |
Procedure: Mechanical thrombectomy combined with ischemic post-conditioning
Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 5 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
|
| Sham Comparator: Control group Mechanical thrombectomy alone |
Procedure: Mechanical thrombectomy alone
Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.
|
Outcome Measures
Primary Outcome Measures
- Infarct volume [72 hours after procedure]
Infarct volume at 72 hours after procedure
Secondary Outcome Measures
- The progression of infarct volume [Baseline and 72 hours after procedure]
Difference of infarct volume between baseline and 72 hours after procedure
- The proportion of functional independence [90 days after procedure]
The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
- The proportion of favorable outcome [90 days after procedure]
The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
- The distribution of the mRS score [90 days after procedure]
The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
- National Institute of Health Stroke Scale (NIHSS) score [24 hours after procedure]
NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
- The proportion of early neurological improvement [24 hours after procedure]
NIHSS 0-2 or ≥8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
- NIHSS score at 7 days after procedure/discharge [7 days after procedure/discharge]
NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
- Recanalization rate [24 hours after procedure]
Recanalization rate at 24 hours after procedure (mTICI ≥2b)
Other Outcome Measures
- Safety outcome (mortality at 90 days) [90 days after procedure]
90-day mortality
- Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) [Within 24 hours after procedure]
The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure
- Safety outcome (the proportion of intracranial hemorrhage within 24 hours) [Within 24 hours after procedure]
The proportion of intracranial hemorrhage within 24 hours after procedure
- Safety outcome (the proportion of malignant brain edema within 24 hours) [Within 24 hours after procedure]
The proportion of malignant brain edema within 24 hours after procedure
- Procedure-related complications [During the procedure]
Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years;
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Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
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Previous mRS ≤ 2;
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Baseline NIHSS ≥ 6;
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Baseline ASPECTS ≥ 6;
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With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
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Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
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Written informed consent provided by the patients or their legal relatives.
Exclusion Criteria:
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Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
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Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
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Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
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2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
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Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
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Patients with contraindications to MRI;
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Other conditions that the investigator considered inappropriate for inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Huanhu Hospital | Tianjin | Tianjin | China | 300350 |
Sponsors and Collaborators
- Capital Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- PROTECT-2