Coronary Artery DiseaseANTELOPENCT02396186
An Assessment of the Glider Balloon in Complex Lesions
An observational study of Coronary Artery Disease, run by TriReme Medical, LLC at 4 sites in United States.
Trial summary
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PTCA Balloon Angioplasty
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to Jun 2017
- How long will I take part?
- 2 Days
- 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: All cases of coronary interventions involving the Glider™ PTCA Balloon Catheter at participating centers will be reviewed for patient eligibility. Patients from all eligible cases should be invited to sign an IRB-approved Informed Consent.
Who may be able to join
- Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
- The Glider balloon may only be used at one lesion during the procedure
- The lesion in which the Glider balloon is used must be completed first
- The primary lesion treated during the procedure must be treated with the Glider balloon
- Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:
- Significant vessel tortuosity
Show all 10Show fewer
- Failed balloon crossing with another balloon
- Tight stenosis
- Heavy calcification
- Side branch present
Who cannot join
- Patient < 18 years of age
- Lesion longer than 40mm
- Device use not consistent with Instructions for Use
- Patient has not given consent for their data to be submitted to this registry
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cardiovascular Specialists of Texas
Austin, Texas, 78758
Alexian Brothers Heart and Vascualr Institute
Elk Grove Village, Illinois, 60007
Washington University in St. Louis
St Louis, Missouri, 63110
York Hospital
York, Pennsylvania, 17403
About this study
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.
Read the detailed description
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.
- Conditions
- Coronary Artery Disease
- Being tested
- PTCA Balloon Angioplasty
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCA Balloon AngioplastyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.
Measured: 1 hour
Secondary outcomes (2)
Freedom from Balloon Slippage
Percentage of inflations with the Glider balloon in which the physician user reports no slippage.
Measured: 1 hour
Lesion Success Rate
Percentage of lesions with <50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- TriReme Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Rizik, MD, Principal investigator, Scottsdale HealthcareWilliam Lombardi, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396186
- Sponsor's protocol ID
- CLP785
- Acronym
- ANTELOPE
- Status last verified
- Sep 2018
- First submitted
- 18 Mar 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Glider Balloon in Complex Lesions
- ClinicalTrials.gov ID
- NCT02396186
- Acronym / sponsor ID
- ANTELOPE / CLP785
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TriReme Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 24 Mar 2015 (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 collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.
Detailed description
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of coronary interventions involving the Glider™ PTCA Balloon Catheter at participating centers will be reviewed for patient eligibility. Patients from all eligible cases should be invited to sign an IRB-approved Informed Consent.
Key inclusion criteria (10 listed)
- Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
- The Glider balloon may only be used at one lesion during the procedure
- The lesion in which the Glider balloon is used must be completed first
- The primary lesion treated during the procedure must be treated with the Glider balloon
- Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:
Key exclusion criteria (4 listed)
- Patient < 18 years of age
- Lesion longer than 40mm
- Device use not consistent with Instructions for Use
- Patient has not given consent for their data to be submitted to this registry
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 |
|---|---|---|
| PTCA Balloon Angioplasty | Device | – |
Primary outcome
Technical Success Rate
Time frame: 1 hour
Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.
2 secondary outcomes
Freedom from Balloon Slippage
Time frame: 1 hour
Lesion Success Rate
Time frame: 48 hours
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 11 Sep 2018.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
David Rizik, MD principal investigator
Scottsdale Healthcare
William Lombardi, MD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by TriReme Medical, LLC at 4 sites 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 10 inclusion and 4 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Rate (time frame: 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 11 Sep 2018.