Coronary DiseaseNCT01184352
Glider PTCA Balloon Catheter Registry
An observational study of Coronary Disease, run by TriReme Medical, LLC at 6 sites in 2 countries.
Trial summary
The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2010to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated by Physicians using the Glider PTCA Balloon Catheter who are willing to participate in the Glider Registry.
Who may be able to join
- Patients undergoing PCI who are at least 18 years old
- PCI procedure included the use of at least one Glider PTCA Balloon Catheter
- Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry
Who cannot join
- N/A
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Vivantes Klinikum Zum Friedrichshain
Berlin
Klinikum Coburg Herzkatheterlabor
Coburg
Alfried Krupp Khs
Essen
Elisabeth-Krankenhaus Essen Kardiologie
Essen
University Klinikum Muenster
Münster
About this study
Official title: Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.
- Conditions
- Coronary Disease
- Being tested
- TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriReme Medical, Inc. Glider(TM) PTCA Balloon CatheterDevice
Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter
| Study group | Role | What they receive |
|---|---|---|
| PCI patients treated with Glider Device | Not described Receives: Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure.
Measured: average of 1 hour
Secondary outcomes (1)
Procedure Success
Percentage of patients treated with at least one Glider PTCA Balloon Catheter having <50% residual diameter stenosis, or TIMI 3 flow if at a bifurcation side branch, without the development of in-hospital MACE (Major Adverse Cardiac Event).
Measured: average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriReme Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo DiMario, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184352
- Sponsor's protocol ID
- CLR734
- Status last verified
- Dec 2012
- First submitted
- 16 Aug 2010
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
- ClinicalTrials.gov ID
- NCT01184352
- Acronym / sponsor ID
- CLR734
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- TriReme Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Aug 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 objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI patients treated with Glider Device | – | Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by Physicians using the Glider PTCA Balloon Catheter who are willing to participate in the Glider Registry.
Key inclusion criteria (3 listed)
- Patients undergoing PCI who are at least 18 years old
- PCI procedure included the use of at least one Glider PTCA Balloon Catheter
- Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| TriReme Medical, Inc. Glider(TM) PTCA Balloon CatheterPercutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter | Device | PCI patients treated with Glider Device |
Primary outcome
Technical Success
Time frame: average of 1 hour
Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure.
1 secondary outcome
Procedure Success
Time frame: average of 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
Carlo DiMario, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by TriReme Medical, LLC at 6 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 1 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: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical Success (time frame: average of 1 hour). 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 6 Dec 2012.