AneurysmPhase 1NCT01101347

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

A Phase 1 study testing Aneurysm-Embolization System in people with Aneurysm, run by Surpass Medical Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aneurysm
What is being tested?: Aneurysm-Embolization System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Start not givento not given
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 21Show fewer

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.

About this study

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

Conditions: Aneurysm
Being tested: Aneurysm-Embolization System
Medical subject headings: Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aneurysm-Embolization SystemDevice

Study groups in NCT01101347
Study group	Role	What they receive
Aneurysm-Embolization System	Experimental	Not described Receives: Device: Aneurysm-Embolization System

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted9 Apr 2010 (estimated)

Why it stopped: Product received Approval for Commercial Distribution

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101347
Sponsor's protocol ID: SP-03
Status last verified: Nov 2010
First submitted: 8 Apr 2010
Last updated: 30 Nov 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
Intracranial Arterial Aneurysm

All Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries
ClinicalTrials.gov ID: NCT01101347
Acronym / sponsor ID: SP-03
Conditions: Aneurysm
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Product received Approval for Commercial Distribution
Enrolment: 10 participants (estimated)
Lead sponsor: Surpass Medical Ltd.Industry (pharma, biotech, devices)
First posted: 9 Apr 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aneurysm-Embolization System	Experimental	Device: Aneurysm-Embolization System

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aneurysm-Embolization System	Device	Aneurysm-Embolization System

Primary outcome

Not reported in the source record.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.

Related trials for Aneurysm

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
Intracranial Arterial Aneurysm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vipul Gupta, MD principal investigator

Medanta, Medcity

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aneurysm-Embolization System in people with Aneurysm, run by Surpass Medical Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.