Catheterization, PeripheralNCT00482742
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
A study testing CiTop(TM) Guidewire in people with Catheterization, Peripheral, run by Ovalum at 3 sites in 2 countries.
Trial summary
The main objectives of the study are: To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology. To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- CiTop(TM) Guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2006to Jun 2013
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinical Inclusion Criteria:
- Patient with symptomatic peripheral vascular disease, intermittent claudication less than 30 meters, rest pain or tissue ischemia.(Fontain grade 3-4)
- Critical limb Ischemia
- The patient has Chronic Total Occlusion in limb arteries, aged at least 3 months.
- Patient has chronic total occlusion (CTO) that is:
- Documented angiographically, by the investigator or co-investigator.
- CTO was defined as an obstruction of a main peripheral artery with no luminal continuity and with TIMI (Thrombolysis In Myocardial Infraction) flow grade of 0 or 1.
- CTO location suitable for endovascular treatment (not in parallel location with the hip or knee joints).
- Lesion ≤ 8cm in length
- Lesion located in a segment with diameter more than 1.5 mm
- Adequate compliance with follow-up and/or repeat angiography
- No Contra-indication to treatment with aspirin or ticlopidine or clopidogrel and/or Heparin
- Visible entry point of target lesion
- NO cancer or other life threatening diseases or conditions
- NO diagnosis or suspected renal failure (2 x ULN of creatinine)
- Not suspected intolerance of the contrast agent
- NO Drug abuse or alcoholism
- Patients is NOT under custodial care
- Women with childbearing potential are NOT pregnant (positive pregnancy test at the time of procedure).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Croatia2 sites
University Hospital Split
Split, 21000
Clinical Hospital Centre Zagreb
Zagreb, 10000
About this study
Official title: A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
The main objectives of the study are:
To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.
To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.
To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.
- Conditions
- Catheterization, Peripheral
- Being tested
- CiTop(TM) Guidewire
- Keywords
- Chronic Total Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiTop(TM) GuidewireDevice
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | Not described Receives: Device: CiTop(TM) Guidewire |
| Metformin | Other | Not described Receives: Device: CiTop(TM) Guidewire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: product development was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovalum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Liat Shochat, Ovalum
- Investigators
- Alexander Belenky, MD, Principal investigator, Research Fund, Belinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482742
- Sponsor's protocol ID
- OVC-P01-00.CTIL
- Status last verified
- Jul 2013
- First submitted
- 3 Jun 2007
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Multi Center Multinational Randomized Open Label Study, to Evaluate the Safety and Performance of the CiTop™ Guidewire for Crossing Total Occlusion in Peripheral Arteries.
- ClinicalTrials.gov ID
- NCT00482742
- Acronym / sponsor ID
- OVC-P01-00.CTIL
- Conditions
- Catheterization, Peripheral
- Keywords
- Chronic Total Occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: product development was cancelled
- Enrolment
- 50 participants (actual)
- Lead sponsor
- OvalumIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Jun 2007 (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 main objectives of the study are:
To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.
To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.
To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Device: CiTop(TM) Guidewire |
| Metformin | Other | Device: CiTop(TM) Guidewire |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CiTop(TM) Guidewire | Device | Lifestyle counseling, Metformin |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: product development was cancelled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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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.
Alexander Belenky, MD principal investigator
Research Fund, Belinson Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CiTop(TM) Guidewire in people with Catheterization, Peripheral, run by Ovalum at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Croatia, Israel. 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?
The study was stopped early (reason given: product development was cancelled). 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 9 Jul 2013.