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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014