Direct Mechanical Thrombectomy Versus Bridging Therapy

NCT05155540 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: 0201218
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.

Conditions

Thrombectomy; Ischemic Stroke; Large-Artery Atherosclerosis (Embolus/Thrombosis)

Keywords

ischemic stroke; Direct mechanical thrombectomy; Bridging therapy

Outcome Measures

Primary Outcomes (2)

• Modified Rankin Scale score

  A measurement of functional independence following ischemic stroke

  3 months

• Complication rate

  The rate and type of complications occuring postoperatively

  within one week postoperatively

Secondary Outcomes (1)

• The National Institutes of Health Stroke Scale (NIHSS) score

  at 24 hours postoperatively

Study Arms (2)

Direct mechanical thrombectomy

ACTIVE COMPARATOR

Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.

Device: Trevo and or Merci devices for stent retreival; Device: Penumbra system for stent aspiration

Bridging therapy

ACTIVE COMPARATOR

Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg

Device: Trevo and or Merci devices for stent retreival; Device: Penumbra system for stent aspiration; Drug: recombinant tissue plasminogen activator

Interventions

Trevo and or Merci devices for stent retreival DEVICE

FDA approved devices for stent retrieval during mechanical thrombectomy

Also known as: No other names

Bridging therapy; Direct mechanical thrombectomy

Penumbra system for stent aspiration DEVICE

FDA approved devices for stent aspiration during mechanical thrombectomy

Bridging therapy; Direct mechanical thrombectomy

recombinant tissue plasminogen activator DRUG

FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset

Bridging therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with anterior ischemic stroke due to large vessel occlusion.
• A previous autonomous modified Rankin Scale (mRS) of less than 2.
• A National Institutes of Health Stroke Scale (NIHSS)≥4
• A groin puncture within 4.5 hours of the neurological deficit onset.

You may not qualify if:

• Imaging documentation of intracranial haemorrhage
• A premorbid mRS score of 2 or more
• Absence of diffusion perfusion mismatch in CT perfusion.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicine

Alexandria, 11523, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Embolism; Thrombosis

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Mohamed A Abdel Ghani, Master's

  Alexandria University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, non-randomized, prospective, double-arm clinical trial

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 13, 2021
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 30 days
• Access Criteria: The data will be available upon request

Locations

EG (1)