Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02779803
Status:
WITHDRAWN
Last Update Posted:
2022-03-04
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STAMCAR: A Prospective EC-IC Bypass Registry
Sponsor:
Lahey Clinic
Organization:
Study Overview
Official Title:
STAMCAR: A Prospective EC-IC Bypass Registry
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study team has made the decision to close this study at this time. No patient data was collected and/or analyzed. Since there was no study funds, contracts and budgets were unable to be drafted and sent to participating sites.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients, specifically, patients with carotid occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan). This subgroup includes:
1. Hospitalized unstable patient with crescendo or postural TIA's
2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy.
1. Hospitalized unstable patient with crescendo or postural TIA's
2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy.
Detailed Description:
The registry is a multi-center international prospective registry. The patients will be prospectively followed for 24 months. Enrollment into the registry will take place over 3 years.
The primary objective is to collect prospective data on cerebral revascularization via superficial temporal artery (STA) to middle cerebral artery (MCA) for symptomatic carotid occlusion patients to determine if the procedure can be performed with less than 8% major peri-operative benchmark.
The secondary objective is to determine if cerebral revascularization via STA to MCA bypass will improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients over a 2 year period.
Clinical outcome in terms of resolved symptomatology, improved cerebrovascular hemodynamics, and cognitive status will be assessed. Short term and long term follow-up for a period of 24 months will include assessment of ipsilateral stroke or TIA rate, mortality, graft patency, assessment of MCA and bypass flow rates (if available), cognitive evaluation and quality of life evaluation.
Following enrollment baseline demographics and operative data will be collected. Follow-up will be performed at 1 month (m), 3m, 6m, 12m and 24m. Occurrence of new TIA or stroke will be determined. The patient's bypass patency, Qualitative Magnetic Resonance Angiogram (QMRA) flow data (site discretion) and NIHSS Score (NIHSS), Barthel Index (mBARTHEL), modified Rankin Scales (mRANKIN), EuroQOL, and the Montreal Cognitive Assessment (MoCA) with digital Clock Drawing (dCDT) will be recorded. An additional battery of neurocognitive tests will also be administered (Symbol Digit Modalities Test SDMT, Delis-Kaplan Executive Function System D-KEFS and TRAILS A/B).
The primary objective is to collect prospective data on cerebral revascularization via superficial temporal artery (STA) to middle cerebral artery (MCA) for symptomatic carotid occlusion patients to determine if the procedure can be performed with less than 8% major peri-operative benchmark.
The secondary objective is to determine if cerebral revascularization via STA to MCA bypass will improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients over a 2 year period.
Clinical outcome in terms of resolved symptomatology, improved cerebrovascular hemodynamics, and cognitive status will be assessed. Short term and long term follow-up for a period of 24 months will include assessment of ipsilateral stroke or TIA rate, mortality, graft patency, assessment of MCA and bypass flow rates (if available), cognitive evaluation and quality of life evaluation.
Following enrollment baseline demographics and operative data will be collected. Follow-up will be performed at 1 month (m), 3m, 6m, 12m and 24m. Occurrence of new TIA or stroke will be determined. The patient's bypass patency, Qualitative Magnetic Resonance Angiogram (QMRA) flow data (site discretion) and NIHSS Score (NIHSS), Barthel Index (mBARTHEL), modified Rankin Scales (mRANKIN), EuroQOL, and the Montreal Cognitive Assessment (MoCA) with digital Clock Drawing (dCDT) will be recorded. An additional battery of neurocognitive tests will also be administered (Symbol Digit Modalities Test SDMT, Delis-Kaplan Executive Function System D-KEFS and TRAILS A/B).
Study Oversight
Has Oversight DMC:
False
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?: