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ASSIST Registry Studying Various Operator Techniques

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ClinicalTrials.gov Identifier: NCT03845491
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Brief Summary:
The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

Condition or disease Intervention/treatment
Ischemic Stroke Device: Mechanical Thrombectomy

Detailed Description:
ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO) in the anterior circulation. Data will be collected on the use of Stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the Registry. This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
SR Classic
SR (Trevo®]) + BGC (FlowGate2] or Merci)
Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy

SR Combination

SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump

+ LS (AXS Infinity LS, AXS Infinity LS Plus)

or

SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci)

Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy

Direct Aspiration

Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus)

or

Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci)

Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy




Primary Outcome Measures :
  1. Severity of disability at Day 90 assessed by modified Rankin Scale (mRS) with a good functional outcome defined by mRS score. [ Time Frame: 90 Days ]
    Severity of disability at Day 90 (± 14) assessed by modified Rankin Scale (mRS) with a good functional outcome defined as mRS of 0-2 for each technique.


Secondary Outcome Measures :
  1. Proportion of subjects with an excellent functional outcome at Day 90 [ Time Frame: 90 Days ]
    Proportion of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14)

  2. Proportion of subjects with an "early response" defined by NIHSS score [ Time Frame: Discharge/ Day 5-7 (Whichever is earlier) ]
    Proportion of subjects with an "early response" at Discharge/Day5-7 (whichever is earlier) defined as a NIHSS drop of ≥10 points from baseline or NIHSS score of 0 or 1

  3. Quality of Life at day 90 based on EQ5D5L score [ Time Frame: Day 90 ]
    Quality of Life at Day 90 (± 14) assessed by EuroQoL (EQ5D5L)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
Criteria

Inclusion Criteria:

  • Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
  • Occlusion of intracranial anterior circulation vessel
  • Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
  • Subject is willing to comply with the protocol follow-up requirements
  • Subject is treated using at least one of the defined techniques for the first pass in the neurovasculature to remove thrombus.

Exclusion Criteria:

  • The subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845491


Contacts
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Contact: Chad Badorek 602-397-6137 chad.badorek@stryker.com
Contact: Alice Lin alice.lin@stryker.com

Locations
Show Show 72 study locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Rishi Gupta, MD WellStar Medical Group
Principal Investigator: Markus Möhlenbruch, MD University Hospital Heidelberg
Additional Information:

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT03845491    
Other Study ID Numbers: T4037
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases