Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02466893
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPASS Trial: a Direct Aspiration First Pass Technique
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
COMPASS Trial: a Direct Aspiration First Pass Technique
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPASS
Brief Summary:
Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials utilizing advanced imaging to identify patients with large vessel occlusions amenable to intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT approach has shown superior technical results with similar functional outcomes while lowering procedure time and device costs versus traditional stent retriever as a first line therapy approaches
Detailed Description:
This is a prospective, randomized trial comparing mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with AIS within 6 hours of symptom onset. Any cleared mechanical stent retriever (SR) or aspiration catheter device that is in common use in the operator's region of practice is approved for use. Prior to releasing any sites to enroll patients, we will collect the following information on the most recent 20 acute ischemic stroke cases, at least five of which must have used direct aspiration as a first approach, and at least five of which must have used stent retrievers as a first approach. It is permissible to go back in time farther than the most recent 20 cases to fulfill either or both of these requirements. There is no requirement for the remaining 10 cases. The datapoints to be collected include:
* Age
* Gender
* LVO location
* Side of LVO
* NIHSS at presentation
* Time of onset
* Time of hospital arrival
* Time imaging completed
* Time of groin puncture
* Time of revascularization, if applicable
* Time procedure terminated, if revascularization was not obtained
* tPA given pre-procedure
* Time of IV-tPA
* Imaging type
* Perfusion imaging
* Devices used
* Passes attempted
* Device success
* Standard and modified final TICI scores
* Outcome measurements: incidence of post-op ICH, discharge and 90 day NIHSS, discharge and 90 day mRS, any and all complications Patients who meet the inclusion and exclusion criteria, consent to participate, and who are randomized will be considered enrolled. Treatment arm will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either ADAPT or SR thrombectomy. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
* Age
* Gender
* LVO location
* Side of LVO
* NIHSS at presentation
* Time of onset
* Time of hospital arrival
* Time imaging completed
* Time of groin puncture
* Time of revascularization, if applicable
* Time procedure terminated, if revascularization was not obtained
* tPA given pre-procedure
* Time of IV-tPA
* Imaging type
* Perfusion imaging
* Devices used
* Passes attempted
* Device success
* Standard and modified final TICI scores
* Outcome measurements: incidence of post-op ICH, discharge and 90 day NIHSS, discharge and 90 day mRS, any and all complications Patients who meet the inclusion and exclusion criteria, consent to participate, and who are randomized will be considered enrolled. Treatment arm will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either ADAPT or SR thrombectomy. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: