STAMCAR: A Prospective EC-IC Bypass Registry

NCT02779803 | Withdrawn

• 1 other identifier: LCID: 2015-034
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

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. 1.Hospitalized unstable patient with crescendo or postural TIA's
2. 2.Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy.

Conditions

Carotid Occlusion

Outcome Measures

Primary Outcomes (4)

• Number of Patients with Ipsilateral Ischemic Stroke

  During surgery

• Number of Patients with Ipsilateral Ischemic Stroke

  Up to 30 days from surgery

• Number of Patients that experience Stroke

  After 30 days from surgery

• Number of Patients that experience Death

  After 30 days from surgery

Secondary Outcomes (11)

• Cerebral Hemodynamic Testing

  baseline, 3 months, 12 months

• Qualitative Magnetic Resonance Angiogram, Non-invasive Optimal Vessel Analysis Blood Flow Data

  baseline, 3 months, 12 months

• Bypass Patency

  3 months, 6 months, 12 months, 24 months

• EuroQOL-5 Dimensions

  baseline, 1 month, 3 months, 6 months, 12 months, 24 months

• Montreal Cognitive Assessment (MoCA)

  baseline, 1 month, 3 months, 6 months, 12 months, 24 months

Interventions

EC-IC bypass PROCEDURE

To determine if cerebral revascularization via STA to MCA bypass to improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with internal carotid artery or middle cerebral artery occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan).

You may qualify if:

• Internal carotid artery or middle cerebral artery occlusion
• Transient ischemic attack (TIA) or ischemic stroke in the ipsilateral hemisphere within 30 days in patients who are either
• hospitalized unstable patients with crescendo or postural TIA's, OR
• Multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy\*
• Evidence of ipsilateral impaired cerebrovascular reserve on physiological testing (e.g. Diamox challenge SPECT)
• Modified Rankin Score (mRS) \>3
• Language comprehension intact
• Age 18-85 years \* failure of medical therapy must include at least failure on a regimen of antiplatelets and statins.

You may not qualify if:

• Moya-moya syndrome
• Known heart disease likely to cause cerebral ischemia
• Prosthetic Valves
• Atrial Fibrillation
• Infective endocarditis
• Left atrial or ventricular thrombus
• Sick sinus syndrome
• Cardiac myxoma
• Cardiomyopathy with ejection fraction \< 25%
• Any condition likely to lead to death within 2 years
• Pregnancy
• Allergy or contraindication to aspirin
• Uncontrolled diabetes mellitus (FBS \> 300 mg%/16.7 mmol/L)
• Uncontrolled hypertension (systolic BP\>180, diastolic BP \>110), other than induced for control of pressure dependent symptoms
• Uncontrolled hypotension (diastolic BP \<65)

Sponsors & Collaborators

• Lahey Clinic: lead
• American Association of Neurological Surgeons: collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803, United States

Location

MeSH Terms

Interventions

Cerebral Revascularization

Intervention Hierarchy (Ancestors)

Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Microsurgery

Study Officials

• Carlos David, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 20, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2021-08

Locations

US (3)