An interventional study of Endovascular Mechanical Thrombectomy in Ischemic Stroke, sponsored by Medical University of South Carolina. Terminated at 20 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
Primary Endpoint:
The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as:
Secondary Endpoints:
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. The rapid progression of thrombectomy devices over the last several years has resulted in faster recanalization times while maintaining a high degree of safety. This has resulted in improved patient outcomes, similar to prior randomized trial data showing improved outcomes over medical therapy or earlier devices. Data from the MERCI trial suggests that patients > 85 as well as those with a baseline NIHSS score > 30 are unlikely to benefit from thrombectomy. Patients with rapidly improving neurologic deficits likely will have an excellent recovery with conventional care, precluding the ability to detect a beneficial treatment effect of thrombectomy.
Pilot data incorporating physiologic imaging has shown that appropriate patients can be selected for thrombectomy. This selection methodology has shown the ability to maintain the same level of safety and efficacy as those patients treated in the highly selective environment of a clinical trial, despite presenting far beyond accepted time based standards. Vertebrobasilar occlusion patients are excluded to maintain a homogenous study population, particularly since no data currently is available addressing the comparability of imaging penumbral patterns in the anterior vs. posterior circulation. This has also been shown to be reproducible at multiple centers and with different imaging modalities. However, all prospective interventional stroke studies performed to date have been restricted by the 8-hour time window.
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Exclusion Criteria:
Head CT or MRI Scan Exclusion Criteria
Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following: * General medical management according to AHA/ASA guidelines * Admission to monitored or intensive care unit for at least 24 hours * Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient * Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician * Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines * Follow-up imaging study required in any patient with neurologic deterioration
Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
Device: Endovascular Mechanical Thrombectomy
Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
Also known as: mechanical revascularization
Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS)
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2. The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, (patients seen within 6 hours of symptom onset will be immediately considered for endovascular therapy according to the site's standard of care. Likewise, patients presenting beyond 12 hours will be treated according to the site's standard of care), with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT.
Time frame: 90 days
Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS)
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 3-6 represents global disability are defined as follows: (3) moderate disability (requiring some help, but able to walk without assistance); (4) moderate severe disability (unable to walk without assistance and unable to attend to own bodily needs without assistance); (5) severe disability (bedridden, incontinent and requiring constant nursing care and attention; and (6) dead.
Time frame: 90 day
Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS)
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 0-2 represents good functional recovery. The scores are defined as follows: (0) No symptoms at all; (1) No significant disability despite symptoms, able to carry out all usual duties and activities; (2) Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance.
Time frame: 90 days
Percentage of Participants Mortality at 30 Days
Mortality at 30 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
Time frame: 30 days
Percentage of Participants Mortality at 90 Days
Mortality at 90 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
Time frame: 90 days
Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4).
ICH with neurological deterioration (NIHSS worsening \>4) will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
Time frame: 90 days
Percentage of Participants With SAE's Related to a Thrombectomy Procedure
A Thrombectomy is an interventional procedure to remove a blood clot (thrombus) from a blood vessel in the brain. Procedure related SAE's will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
Time frame: 90 days
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Arterial revascularization measured by TICI 2b or 3 following device use will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
Time frame: 90 days
Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device.
A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus).
Time frame: 90 days
| Milestone | Medical Therapy | Endovascular Treatment (Thrombectomy Procedure |
|---|---|---|
| Started | 21 | 12 |
| Completed | 21 | 12 |
| Not completed | 0 | 0 |
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2. The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, (patients seen within 6 hours of symptom onset will be immediately considered for endovascular therapy according to the site's standard of care. Likewise, patients presenting beyond 12 hours will be treated according to the site's standard of care), with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) | 42.9 | 75 |
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 3-6 represents global disability are defined as follows: (3) moderate disability (requiring some help, but able to walk without assistance); (4) moderate severe disability (unable to walk without assistance and unable to attend to own bodily needs without assistance); (5) severe disability (bedridden, incontinent and requiring constant nursing care and attention; and (6) dead.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS) | 62.5 | 50 |
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 0-2 represents good functional recovery. The scores are defined as follows: (0) No symptoms at all; (1) No significant disability despite symptoms, able to carry out all usual duties and activities; (2) Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance.
| Percentage of particpants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS) | 42.9 | 75.0 |
Mortality at 30 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants Mortality at 30 Days | 12 | 0 |
Mortality at 90 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants Mortality at 90 Days | 19.1 | 8.3 |
ICH with neurological deterioration (NIHSS worsening \>4) will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4). | 0 | 0 |
A Thrombectomy is an interventional procedure to remove a blood clot (thrombus) from a blood vessel in the brain. Procedure related SAE's will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
| Percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Participants With SAE's Related to a Thrombectomy Procedure | 0.0 | 8.3 |
Arterial revascularization measured by TICI 2b or 3 following device use will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Arterial Revascularization Measured by TICI 2b or 3 Following Device Use | 100 | 83 |
A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus).
| percentage of participants | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device. | 0 | 0 |
Collected over Adverse event data was collected over the duration of the study-104 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Best Medical Therapy | 4/21 (19%) | 12/21 (57.1%) | 10/21 (47.6%) |
| Endovascular Treatment | 1/12 (8.3%) | 4/12 (33.3%) | 9/12 (75%) |
| Event | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Asymptomatic intracranial hemorrhage up to 24 hours post-randomizationVascular disorders | 2/21 | 4/12 |
| Neurologic DeteriorationVascular disorders | 3/21 | 0/12 |
| Peripheal thromboembolic eventVascular disorders | 0/21 | 1/12 |
| Worsening of Pre Existing Condition-Mid Sternal Chest PainCardiac disorders | 0/21 | 1/12 |
| L Hip dislocation requiring closed reductionMusculoskeletal and connective tissue disorders | 0/21 | 1/12 |
| Accidental narcotic overdoseGeneral disorders | 0/21 | 1/12 |
| Cardiac ArrestCardiac disorders | 0/21 | 1/12 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/21 | 0/12 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/21 | 0/12 |
| Worsening of pre-exist. cond.- Severely reduced LV, mildly reduced RV systolic functionVascular disorders | 1/21 | 0/12 |
| Event | Best Medical Therapy | Endovascular Treatment |
|---|---|---|
| Distal EmboliVascular disorders | 0/21 | 2/12 |
| Neurological Deterioration (increase of >4 points on NIHSS)Vascular disorders | 3/21 | 0/12 |
| ArrythmiaCardiac disorders | 2/21 | 1/12 |
| DiarrheaGastrointestinal disorders | 2/21 | 0/12 |
| BactermiaInfections and infestations | 2/21 | 0/12 |
| HeadacheGeneral disorders | 2/21 | 0/12 |
| Groin puncture site: hematomaVascular disorders | 0/21 | 1/12 |
| VasospasmVascular disorders | 0/21 | 1/12 |
| Low HemoglobinBlood and lymphatic system disorders | 0/21 | 1/12 |
| AnemiaBlood and lymphatic system disorders | 0/21 | 1/12 |
| Age, Continuous(years) | Best Medical Therapy | Endovascular Treatment | Total |
|---|---|---|---|
| Mean | 65 ± 13 | 70 ± 10.1 | 67 ± 12.1 |
| Sex: Female, Male(Participants) | Best Medical Therapy | Endovascular Treatment | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 13 | 4 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Best Medical Therapy | Endovascular Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 12 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Best Medical Therapy | Endovascular Treatment | Total |
|---|---|---|---|
| United States | 21 | 12 | 33 |
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Medical University of South Carolina