Stroke, IschemicTRAPNCT03199404
Trevo Aspiration Proximal Flow Control Registry
An observational study of Stroke, Ischemic, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- TRAP
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 3 Oct 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.
Who may be able to join
- Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)
- Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
- Subjects that range in age from 18-85
- Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
- Subjects that the operator feels may be treated with endovascular therapy
- Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better
- Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)
- Subjects who have consented in accordance with local Institutional Review Board requirements
Who cannot join
- Absence of large vessel occlusion on neuroimaging
- Evidence of tandem occlusion on neuroimaging
- Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction
- Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
- Previously documented contrast allergy that is not amenable to medical treatment
- Women who are pregnant or breastfeeding at time of intervention
- Evidence of brain hemorrhage on CT and/or MRI at presenting hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Worcester, Massachusetts, 01501
About this study
Official title: TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry
This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.
Read the detailed description
The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.
- Conditions
- Stroke, Ischemic
- Being tested
- TRAP
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAPDevice
Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.
| Study group | Role | What they receive |
|---|---|---|
| Treated Subjects | Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) and in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel and that meet the other inclusion-exclusion criteria. Receives: Device: TRAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization after Endovascular Intervention
Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels
Measured: Day 0: Conclusion of Thrombectomy Procedure
Time to Recanalization
The time required to attain recanalization (TICI 2b/3) in affected vessels
Measured: Day 0: Conclusion of Thrombectomy Procedure
Number of Passes for Recanalization
The total number of passes with the stent retriever need to attain recanalization will be captured.
Measured: Day 0: Conclusion of Thrombectomy Procedure
Distal Emboli
Incidence of distal emboli (both to affected vessel and new vessel) will be assessed
Measured: Day 0: Conclusion of Thrombectomy Procedure
Secondary outcomes (4)
Neurologic Outcomes
Neurologic recovery as assessed by the National Institutes of Health Stroke Scale
Measured: 90 days after treatment
Functional Outcomes
Neurologic recovery as assessed by the Modified Rankin Scale
Measured: 90 days after treatment
Adverse Events
Incidence of serious procedure-related adverse events will be captured
Measured: Day 1, Day 5-7 and Day 90
TRAP Technique
Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist
Measured: Day 0: Conclusion of thrombectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start6 Jun 2017
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Why it stopped: Lead site preference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- 38 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular
- Responsible party
- Principal investigator, Ajit Puri, University of Massachusetts, Worcester
- Investigators
- Ajit Puri, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199404
- Sponsor's protocol ID
- TRAPv1.9
- Acronym
- TRAP
- Status last verified
- Oct 2019
- First submitted
- 12 Jun 2017
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry
- ClinicalTrials.gov ID
- NCT03199404
- Acronym / sponsor ID
- TRAP / TRAPv1.9
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lead site preference
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Stryker Neurovascular
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.
Detailed description
The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Subjects | – | Device: TRAPSubject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) and in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel and that meet the other inclusion-exclusion criteria. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.
Key inclusion criteria (8 listed)
- Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)
- Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
- Subjects that range in age from 18-85
- Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
- Subjects that the operator feels may be treated with endovascular therapy
Key exclusion criteria (7 listed)
- Absence of large vessel occlusion on neuroimaging
- Evidence of tandem occlusion on neuroimaging
- Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction
- Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
- Previously documented contrast allergy that is not amenable to medical treatment
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 |
|---|---|---|
| TRAPMechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy. | Device | Treated Subjects |
Primary outcome
Recanalization after Endovascular Intervention
Time frame: Day 0: Conclusion of Thrombectomy Procedure
Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels
Time to Recanalization
Time frame: Day 0: Conclusion of Thrombectomy Procedure
The time required to attain recanalization (TICI 2b/3) in affected vessels
Number of Passes for Recanalization
Time frame: Day 0: Conclusion of Thrombectomy Procedure
The total number of passes with the stent retriever need to attain recanalization will be captured.
Distal Emboli
Time frame: Day 0: Conclusion of Thrombectomy Procedure
Incidence of distal emboli (both to affected vessel and new vessel) will be assessed
4 secondary outcomes
Neurologic Outcomes
Time frame: 90 days after treatment
Functional Outcomes
Time frame: 90 days after treatment
Adverse Events
Time frame: Day 1, Day 5-7 and Day 90
TRAP Technique
Time frame: Day 0: Conclusion of thrombectomy procedure
Results and safety
The study was stopped early (reason given: Lead site preference). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ajit Puri, MD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by University of Massachusetts, Worcester at 1 site in United States.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Lead site preference). Results are not available in the source record.
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?
Recanalization after Endovascular Intervention (time frame: Day 0: Conclusion of Thrombectomy Procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2019.