Coronary Chronic Total OcclusionNCT00733070
Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
A study testing CiTop™ ExPander™ Guidewire in people with Coronary Chronic Total Occlusion, run by Ovalum at 3 sites in 2 countries.
Trial summary
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Chronic Total Occlusion
- What is being tested?
- CiTop™ ExPander™ Guidewire
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2008to 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained prior to any trial activities.
- Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
- Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Who cannot join
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Factors making follow-up and/or repeat angiography difficult or unlikely.
- Contra-indication to emergency artery by pass surgery.
- Lack of surgical backup.
- Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
Show all 21Show fewer
- Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
- Treated vessel referenced diameter less than 2.5 mm.
- Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
- Non-visible entry point of target lesion.
- Totally occluded bypass graft as target vessel.
- Acute MI less than 1 week before procedure.
- Patient has significant LV dysfunction, 35% LVEF or less.
- Patient with cancer or other sever chronic disease with life expectance of 2 years.
- Patient has chronic renal failure with serum creatinine ≥2.
- Hemoglobin ≤11.
- Patient is known or suspected not to tolerate the contrast agent.
- Morbid Obesity (BMI > 40).
- Drug abuse or alcoholism.
- Patients under custodial care.
- Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
Sunward Park Hospital
Boksburg
Sunninghill Hospital
Sunninghill, 2157
About this study
Official title: A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
- Conditions
- Coronary Chronic Total Occlusion
- Being tested
- CiTop™ ExPander™ Guidewire
- Keywords
- CTO, Chronic Total Occlusion, Revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiTop™ ExPander™ GuidewireDevice
Chronic Total Occlusion guidewire
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
Measured: during procedure, 1day, 1week and 30 days post procedure
Secondary outcomes (6)
Successful stenting
Measured: During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration
Measured: during procedure
Fluoroscopy time
Measured: during procedure
Amount of contrast
Measured: during procedure
Maneuverability of the CiTop™ up to the occlusion
Measured: during procedure
No mechanical damage to the device during
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: no interest to develop the product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Chronic Total OcclusionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ovalum
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733070
- Sponsor's protocol ID
- OVC-003-00
- Status last verified
- Jul 2013
- First submitted
- 10 Aug 2008
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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 Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
- ClinicalTrials.gov ID
- NCT00733070
- Acronym / sponsor ID
- OVC-003-00
- Conditions
- Coronary Chronic Total Occlusion
- Keywords
- CTO, Chronic Total Occlusion, Revascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no interest to develop the product
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OvalumIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Aug 2008 (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.
A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent obtained prior to any trial activities.
- Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
- Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
Key exclusion criteria (21 listed)
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Factors making follow-up and/or repeat angiography difficult or unlikely.
- Contra-indication to emergency artery by pass surgery.
- Lack of surgical backup.
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™ ExPander™ GuidewireChronic Total Occlusion guidewire | Device | – |
Primary outcome
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications
Time frame: during procedure, 1day, 1week and 30 days post procedure
6 secondary outcomes
Successful stenting
Time frame: During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Amount of contrast
Time frame: during procedure
Maneuverability of the CiTop™ up to the occlusion
Time frame: during procedure
No mechanical damage to the device during
Time frame: during procedure
Results and safety
The study was stopped early (reason given: no interest to develop the product). 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.
The record lists no contact. Use the official record to reach the sponsor.
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™ ExPander™ Guidewire in people with Coronary Chronic Total Occlusion, 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?
The sponsor lists 3 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: 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 South Africa, Germany. 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: no interest to develop the product). 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.
What does the primary outcome measure?
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications (time frame: during procedure, 1day, 1week and 30 days post procedure). It is what the study was designed to measure, not a finding.
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.