A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries

NCT01101347 | Withdrawn Phase 1 DMC

• 1 other identifier: SP-03
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.

Conditions

Aneurysm

Study Arms (1)

Aneurysm-Embolization System

EXPERIMENTAL

Device: Aneurysm-Embolization System

Interventions

Aneurysm-Embolization System DEVICE

Aneurysm-Embolization System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject understands the nature of the procedure and provides written informed consent.
• Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
• Age 18 years to 80 years.
• Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of \> 2mm and \< 6mm.

You may not qualify if:

• Pregnancy
• Enrollment in another trial
• Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
• History of life threatening allergy to contrast dye.
• Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
• Severe neurological deficit that renders the patient incapable of living independently
• Dementia or psychiatric problem that prevents the patient from completing required follow up
• Co-morbid conditions that may limit survival to less than one year
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
• Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
• Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
• Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
• Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
• Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date

Sponsors & Collaborators

• Surpass Medical Ltd.: lead

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vipul Gupta, MD

  Medanta, Medcity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Last Updated: November 30, 2010

Record last verified: 2010-11