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

This study has been withdrawn prior to enrollment.
(Product received Approval for Commercial Distribution)
Sponsor:
Information provided by:
Surpass Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01101347
First received: April 8, 2010
Last updated: November 26, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Aneurysm
Device: Aneurysm-Embolization System
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries

Resource links provided by NLM:


Further study details as provided by Surpass Medical Ltd.:

Estimated Enrollment: 10
Arms Assigned Interventions
Experimental: Aneurysm-Embolization System Device: Aneurysm-Embolization System

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
  • Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
  • Subject with resistance to ASA and/or Clopidogrel.
  • Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
  • Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
  • Target aneurysm is expected to require more than one device.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101347

Sponsors and Collaborators
Surpass Medical Ltd.
Investigators
Principal Investigator: Vipul Gupta, MD Medanta, Medcity
  More Information

No publications provided

Responsible Party: Marc Litzenberg, Surpass Medical, Ltd
ClinicalTrials.gov Identifier: NCT01101347     History of Changes
Other Study ID Numbers: SP-03
Study First Received: April 8, 2010
Last Updated: November 26, 2010
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014