Ischemic StrokeNCT03845491
ASSIST Registry Studying Various Operator Techniques
An observational study of Ischemic Stroke, run by Stryker Neurovascular at 72 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Medical device
- How many people
- 1,492 participants
- Where
- 72 sitesin 11 countries
- Study dates
- 24 Jan 2019to 25 Jan 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subjects who experienced acute ischemic stroke (AIS), 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
- The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions For Use (IFU): Technique Category/Devices: SR Classic/SR + BGC, SR Combination/SR + Asp Cath ± Pump + BGC or LS, Direct Aspiration/Asp Cath ± Pump + BGC or LS,
Who cannot join
- 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.
Trial locations and contacts
72 sites in 11 countries.
72 sites in 11 countries
United States38 sites
Buffalo University
Buffalo, New York, 14203
MUSC
Charleston, South Carolina, 29425
Riverside Methodist- OHRI
Columbus, Ohio, 43214
Geisinger Medical Center
Danville, Pennsylvania, 17822
St. Mary's Medical Center
Delray Beach, Florida, 33484
University Medical Center- El Paso
El Paso, Texas, 79901
McLaren Regional Medical Facility
Flint, Michigan, 48532
Kaiser Permanente Fontana
Fontana, California, 92335
Valley Baptist Harlingen
Harlingen, Texas, 78550
Memorial Healthcare System
Hollywood, Florida, 33021
Indiana University
Indianapolis, Indiana, 46202
Baptist Jacksonville
Jacksonville, Florida, 32207
Kansas University Medical Center
Kansas City, Kansas, 66160
Sparrow Health
Lansing, Michigan, 48912
Kaiser Permanente LA
Los Angeles, California, 90027
UCLA Medical Center
Los Angeles, California, 90095
WellStar Health System/ Kennestone Hospital
Marietta, Georgia, 30060
Semmes Murphey Foundation
Memphis, Tennessee, 38120
Banner Desert
Mesa, Arizona, 85202
Aurora St. Luke's
Milwaukee, Wisconsin, 53215
Doctors Medical Center Modesto
Modesto, California, 95350
West Virginia University Hospital
Morgantown, Virginia, 26506
Mount Sinai
New York, New York, 10029
Advocate Hospital
Oak Lawn, Illinois, 60453
University of Oklahoma Medical Center (OU - OKC)
Oklahoma City, Oklahoma, 73104
UC Irvine
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Legacy Emanuel Medical Center
Portland, Oregon, 97232
Rhode Island Hospital
Providence, Rhode Island, 02903
Dignity Health/ Mercy San Juan
Rancho Cordova, California, 95670
William Beaumont Hospital
Royal Oak, Michigan, 48073
Stanford
Stanford, California, 94305
University of S. Florida/Tampa General
Tampa, Florida, 33620
Montefiore Medical Center
The Bronx, New York, 10467
Mercy St. Vincent
Toledo, Ohio, 43608
Westchester Medical Center
Valhalla, New York, 10595
UMASS
Worcester, Massachusetts, 01655
Spain8 sites
Hospital Vall de Hebron
Barcelona, 08035
Hospital de la Princesa
Madrid, 28010
Hospital Clinico San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid
Hospital Universitario Central de Asturias - HUCA
Oviedo, Vigo, 33011
Hospital Son Espases de Mallorca
Palma de Mallorca, 7120
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47003
Germany6 sites
Klinikum Dortmund
Dortmund, 44137
University Hospital Heidelberg
Heidelberg, 69120
Klinikum Kassel
Kassel
Klinikum Rechts Der Isar
Munich, 81675
Klinikum LMU
Munich
Klinikum Vest Recklinghausen
Recklinghausen, 45657
Italy6 sites
Ospedale Policlinico san Martino
Genova
AOPU G. Martino
Messina
AO Parma
Parma, 43100
AO San Camillo Forlanini
Roma
Azienda Ospedaliera Siena
Siena, 53100
AO Modena
Via Giardini, 1355
France4 sites
CHU Bordeaux_GH Pellegrin
Bordeaux
Hospital Cavale Blanche CHU Brest
Brest, 29200
CHU Lyon- Hopital P. Wertheimer
Bron
CHU Rouen
Rouen
Switzerland3 sites
University Hospital Basel
Basel, 4031
HUG Geneva
Geneva
CHUV
Lausanne
Belgium2 sites
Ghent University Hospital
Ghent
AZ Sint-Jan AV Brugge Oostende
Ostend
South Korea2 sites
Cheonnam University Hospital
Gwangju
The Catholic University of Korea, St. Vincent's Hospital
Suwon
About this study
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).
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).
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyDevice
Treatment of LVO with mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| SR Classic | SR (Trevo®]) + BGC (FlowGate2] or Merci) Receives: 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) Receives: 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) Receives: Device: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.
Measured: 90 Days (±14 days)
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization.
The Expanded TICI (eTICI) Perfusion Score Categories are:
- 0: Equivalent to no reperfusion or 0% filling of the downstream territory
- 1: Reflects thrombus reduction without any reperfusion of distal arteries
- 2a: Reperfusion in less than half or 1-49% of the territory
- 2b50: 50-66% reperfusion
- 2b67: 67-89% reperfusion
- 2c: 90-99% reperfusion
- 3: Complete or 100% reperfusion
Measured: At the time of procedure, after the first pass
Secondary outcomes (6)
Percentage of Subjects With an Excellent Functional Outcome at Day 90
Percentage of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14).
Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all, no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability.
Measured: 90 Days (±14 days)
Percentage of Subjects With an "Early Response" Defined by NIHSS Score
Percentage 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.
NIHSS (National Institutes of Health Stroke Scale) is an assessment to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: Discharge/ Day 5-7 (Whichever is earlier)
Quality of Life at Day 90 Based on EQ5D5L Score
The Euro Quality of Life Questionnaire - 5 Level 5D Version (EQ5D5L) is composed of 5 dimensions- mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated by the subject on 5 level scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The outcome reported shows severe and extreme levels were combined and only 4 levels are reported.
Measured: Day 90 (±14 days)
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
This outcome reports percentage of subjects who achieved eTICI 2b50, eTICI 2b67, eTICI 2c,or eTICI 3 on first pass after primary technique used and at the end of the endovascular procedure.
Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization.
The Expanded TICI (eTICI) Perfusion Score Categories are:
- 0: Equivalent to no reperfusion or 0% filling of the downstream territory
- 1: Reflects thrombus reduction without any reperfusion of distal arteries
- 2a: Reperfusion in less than half or 1-49% of the territory
- 2b50: 50-66% reperfusion
- 2b67: 67-89% reperfusion
- 2c: 90-99% reperfusion
- 3: Complete or 100% reperfusion
Measured: At the time of procedure, after the first pass, and at the end of the procedure
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
This outcome measures overall time (in minutes) observed from groin puncture to the specific eTICI reperfusion score at end of first pass for treatment of target occlusion. Each subject can only be in one eTICI category and therefore they are mutually exclusive.
Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization.
The Expanded TICI (eTICI) Perfusion Score Categories are:
- 0: Equivalent to no reperfusion or 0% filling of the downstream territory
- 1: Reflects thrombus reduction without any reperfusion of distal arteries
- 2a: Reperfusion in less than half or 1-49% of the territory
- 2b50: 50-66% reperfusion
- 2b67: 67-89% reperfusion
- 2c: 90-99% reperfusion
- 3: Complete or 100% reperfusion
Measured: During the procedure, from groin puncture to after the first pass
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
This outcome measures the overall time (in minutes) observed from groin puncture to final reperfusion of eTICI 2c or 3 for treatment of target occlusion.
Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization.
The Expanded TICI (eTICI) Perfusion Score Categories are:
- 0: Equivalent to no reperfusion or 0% filling of the downstream territory
- 1: Reflects thrombus reduction without any reperfusion of distal arteries
- 2a: Reperfusion in less than half or 1-49% of the territory
- 2b50: 50-66% reperfusion
- 2b67: 67-89% reperfusion
- 2c: 90-99% reperfusion
- 3: Complete or 100% reperfusion
Measured: Time of procedure, from groing puncture to revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start24 Jan 2019
- Primary completion11 Apr 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,492 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rishi Gupta, MD, Principal investigator, WellStar Medical GroupMarkus Möhlenbruch, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845491
- Sponsor's protocol ID
- CDM10001414
- Status last verified
- Apr 2025
- First submitted
- 15 Feb 2019
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Khezri N, Luff MK, Miralbes S, Naravetla B, Spiotta A, Loehr C, Martinez-Galdamez M, McTaggart R, Defreyne L, Vega P, Zaidat OO, Price LL, Gupta R, Mohlenbruch M, Liebeskind DS. Clinical and Demographic Factors Associated With Hemorrhagic Transformation Subtypes After Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke Vasc Interv Neurol. 2026 Jul 21;6(5):e001899. doi: 10.1161/SVIN.125.001899. eCollection 2026 Sep.
PubMed 42707786Ashouri Y, AlMajali M, Olvany JM, Chaudhari A, Miralbes S, Naravetla B, Spiotta A, Lin E, Loehr C, Martinez-Galdamez M, McTaggart R, Defreyne L, Vega P, Chaubal V, Jenkins P, Liebeskind DS, Gupta R, Mohlenbruch M, Zaidat OO. Clinical and Angiographic Outcomes in Patients With Tandem Occlusion Thrombectomy: Analysis From the ASSIST International Registry. Stroke Vasc Interv Neurol. 2026 Mar 20;6(3):e002157. doi: 10.1161/SVIN.125.002157. eCollection 2026 May.
PubMed 42088322Molaie A, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Jenkins P, Mohlenbruch M, Gupta R, Liebeskind DS; ASSIST Investigators. Incomplete reperfusion and the presence of distal emboli in predicting clinical outcome after endovascular thrombectomy. BMJ Surg Interv Health Technol. 2025 Apr 10;7(1):e000345. doi: 10.1136/bmjsit-2024-000345. eCollection 2025.
PubMed 40226203Luff MK, Khezri N, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Price LL, Gupta R, Mohlenbruch MA, Liebeskind DS; ASSIST Investigators. Hemorrhagic transformation in acute ischemic stroke: hemorrhagic subtypes and symptomatic intracranial hemorrhage. J Neurointerv Surg. 2025 Jun 16;17(7):673-682. doi: 10.1136/jnis-2024-021725.
PubMed 38969497
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03845491
- Acronym / sponsor ID
- CDM10001414
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,492 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SR Classic | – | Device: Mechanical ThrombectomySR (Trevo®]) + BGC (FlowGate2] or Merci) |
| SR Combination | – | Device: Mechanical ThrombectomySR (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) |
| Direct Aspiration | – | Device: Mechanical ThrombectomyAsp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Subjects who experienced acute ischemic stroke (AIS), 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
- The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions For Use (IFU): Technique Category/Devices: SR Classic/SR + BGC, SR Combination/SR + Asp Cath ± Pump + BGC or LS, Direct Aspiration/Asp Cath ± Pump + BGC or LS,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ThrombectomyTreatment of LVO with mechanical thrombectomy | Device | Direct Aspiration, SR Classic, SR Combination |
Primary outcome
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
Time frame: 90 Days (±14 days)
This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
Time frame: At the time of procedure, after the first pass
This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion
6 secondary outcomes
Percentage of Subjects With an Excellent Functional Outcome at Day 90
Time frame: 90 Days (±14 days)
Percentage of Subjects With an "Early Response" Defined by NIHSS Score
Time frame: Discharge/ Day 5-7 (Whichever is earlier)
Quality of Life at Day 90 Based on EQ5D5L Score
Time frame: Day 90 (±14 days)
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
Time frame: At the time of procedure, after the first pass, and at the end of the procedure
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
Time frame: During the procedure, from groin puncture to after the first pass
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
Time frame: Time of procedure, from groing puncture to revascularization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42707786Khezri N, Luff MK, Miralbes S, Naravetla B, Spiotta A, Loehr C, Martinez-Galdamez M, McTaggart R, Defreyne L, Vega P, Zaidat OO, Price LL, Gupta R, Mohlenbruch M, Liebeskind DS. Clinical and Demographic Factors Associated With Hemorrhagic Transformation Subtypes After Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke Vasc Interv Neurol. 2026 Jul 21;6(5):e001899. doi: 10.1161/SVIN.125.001899. eCollection 2026 Sep.
- Derived from this study: PubMed 42088322Ashouri Y, AlMajali M, Olvany JM, Chaudhari A, Miralbes S, Naravetla B, Spiotta A, Lin E, Loehr C, Martinez-Galdamez M, McTaggart R, Defreyne L, Vega P, Chaubal V, Jenkins P, Liebeskind DS, Gupta R, Mohlenbruch M, Zaidat OO. Clinical and Angiographic Outcomes in Patients With Tandem Occlusion Thrombectomy: Analysis From the ASSIST International Registry. Stroke Vasc Interv Neurol. 2026 Mar 20;6(3):e002157. doi: 10.1161/SVIN.125.002157. eCollection 2026 May.
- Derived from this study: PubMed 40226203Molaie A, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Jenkins P, Mohlenbruch M, Gupta R, Liebeskind DS; ASSIST Investigators. Incomplete reperfusion and the presence of distal emboli in predicting clinical outcome after endovascular thrombectomy. BMJ Surg Interv Health Technol. 2025 Apr 10;7(1):e000345. doi: 10.1136/bmjsit-2024-000345. eCollection 2025.
- Derived from this study: PubMed 38969497Luff MK, Khezri N, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Price LL, Gupta R, Mohlenbruch MA, Liebeskind DS; ASSIST Investigators. Hemorrhagic transformation in acute ischemic stroke: hemorrhagic subtypes and symptomatic intracranial hemorrhage. J Neurointerv Surg. 2025 Jun 16;17(7):673-682. doi: 10.1136/jnis-2024-021725.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishi Gupta, MD principal investigator
WellStar Medical Group
Markus Möhlenbruch, MD principal investigator
University Hospital Heidelberg
72 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Stryker Neurovascular at 72 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Spain, Germany, Italy, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 (time frame: 90 Days (±14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845491, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.