To Determine the Safety and Validity of Venous Angioplasty andResrch_Reg_2NCT01593891
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
An observational study of To Determine the Safety and Validity of Venous Angioplasty and and Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, run by Synergy Health Concepts, Inc. at 1 site in United States.
Trial summary
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, Allow Researchers to Sub-classify Valve Morphology in Relation
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Many questions remain about how and when CCSVI might play a role in nervous system damage and whether venous angioplasty is helpful in treating the symptoms of CCSVI. Utilizing intravascular ultrasound (IVUS,) this pilot study will provide data that will allow researchers to evaluate venous morphology pre- and post- percutaneous angioplasty and sub-classify valve morphology as related to treatment success by distinguishing vessels which are more responsive to treatment. In addition, this study will validate the safety of valvuloplasty in various neurodegenerative disorders that involve venous obstruction.
Who may be able to join
- Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
- Males or Females between the ages of 20 and 60 years of age.
- Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment.
Who cannot join
- Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
- History of uncontrolled hypertension
- Previous CCSVI treatment
- Presence of hypercoagulable state
- Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Synergy Health Concepts Inc.
Newport Beach, California, 92660
About this study
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
Read the detailed description
To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.
- Conditions
- To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, Allow Researchers to Sub-classify Valve Morphology in Relation, to Treatment Success. This Will be Evidenced by Venous Patency, Forty-eight Hours by Doppler Ultrasound as Well as Clinical, Symptom Improvement.
- Keywords
- IVUS, CCSVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startAug 2011
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Safety and Validity of Venous Angioplasty andStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synergy Health Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Arata, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593891
- Sponsor's protocol ID
- RESEARCH_REGISTRY_2
- Acronym
- Resrch_Reg_2
- Status last verified
- May 2012
- First submitted
- 6 May 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
- ClinicalTrials.gov ID
- NCT01593891
- Acronym / sponsor ID
- Resrch_Reg_2 / RESEARCH_REGISTRY_2
- Conditions
- To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, Allow Researchers to Sub-classify Valve Morphology in Relation, to Treatment Success. This Will be Evidenced by Venous Patency, Forty-eight Hours by Doppler Ultrasound as Well as Clinical, Symptom Improvement.
- Keywords
- IVUS, CCSVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Synergy Health Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Study completion
- Sep 2012 (estimated)
- First posted
- 8 May 2012 (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.
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
Detailed description
To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Many questions remain about how and when CCSVI might play a role in nervous system damage and whether venous angioplasty is helpful in treating the symptoms of CCSVI. Utilizing intravascular ultrasound (IVUS,) this pilot study will provide data that will allow researchers to evaluate venous morphology pre- and post- percutaneous angioplasty and sub-classify valve morphology as related to treatment success by distinguishing vessels which are more responsive to treatment. In addition, this study will validate the safety of valvuloplasty in various neurodegenerative disorders that involve venous obstruction.
Key inclusion criteria (3 listed)
- Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
- Males or Females between the ages of 20 and 60 years of age.
- Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment.
Key exclusion criteria (5 listed)
- Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
- History of uncontrolled hypertension
- Previous CCSVI treatment
- Presence of hypercoagulable state
- Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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.
Michael Arata, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Determine the Safety and Validity of Venous Angioplasty and and Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, run by Synergy Health Concepts, Inc. at 1 site in United States.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
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 8 May 2012.