ASSIST Registry Studying Various Operator Techniques

• ClinicalTrials.gov Identifier: NCT03845491
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: April 13, 2023
• Sponsor: Stryker Neurovascular
• Information provided by (Responsible Party): Stryker Neurovascular

Tracking Information

• First Submitted Date: February 15, 2019
• First Posted Date: February 19, 2019
• Last Update Posted Date: April 13, 2023
• Actual Study Start Date: January 23, 2019
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2019)

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.

Original Primary Outcome Measures (submitted: February 15, 2019)

Good functional outcome [ Time Frame: 90 Days ]

mRS 0-2

Current Secondary Outcome Measures (submitted: February 19, 2019)

• 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)
• 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
• 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)

Original Secondary Outcome Measures (submitted: February 15, 2019)

• Excellent functional outcome [ Time Frame: 90 Days ]
  mRS 0-1
• Early Response [ Time Frame: Discharge/ Day 5-7 (Whichever is earlier) ]
  NIHSS drop of 10 or more points compared to baseline or NIHSS of 0 or 1
• Quality of Life [ Time Frame: Day 90 ]
  EQ5D

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ASSIST Registry Studying Various Operator Techniques
• 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).
• 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).
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 90 Days
• Biospecimen: Not Provided
• 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
• Condition: Ischemic Stroke

Intervention

Device: Mechanical Thrombectomy

Treatment of LVO with mechanical thrombectomy

Study Groups/Cohorts

• SR Classic
  SR (Trevo®]) + BGC (FlowGate2] or Merci)
  Intervention: Device: 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)

  Intervention: Device: 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)

  Intervention: Device: Mechanical Thrombectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 12, 2019): 1500
• Original Estimated Enrollment (submitted: February 15, 2019): 2000
• Actual Study Completion Date: January 25, 2023
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Czechia, France, Germany, Italy, Korea, Republic of, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03845491
• Other Study ID Numbers: CDM10001414
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stryker Neurovascular
• Original Responsible Party: Same as current
• Current Study Sponsor: Stryker Neurovascular
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rishi Gupta, MD; WellStar Medical Group
• Principal Investigator: Markus Möhlenbruch, MD; University Hospital Heidelberg

• PRS Account: Stryker Neurovascular
• Verification Date: April 2023