Peripheral Arterial DiseaseChocolate BARNCT01589042
Chocolate Balloon Angioplasty Registry
An observational study of Peripheral Arterial Disease, run by TriReme Medical, LLC at 13 sites in United States.
Trial summary
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 490 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2012to Dec 2015
- 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 with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty
Who may be able to join
- >18 years of age
- Lesion successfully crossed with a guide-wire
- Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
- Patient has given consent for their information to be submitted to this registry
Who cannot join
- Lesion required stenting as the primary treatment approach
- Life expectancy <12 months
- Patient is enrolled in another clinical study that may impact the results of this registry
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Cardiovascular Research of Dallas
Dallas, Texas
VA North Texas
Dallas, Texas
St. John's Hospital
Detroit, Michigan
Alexian Brothers Heart and Vascular
Elk Grove Village, Illinois
Cardiovascular Research of North Florida
Gainesville, Florida
Jackson Heart Clinic
Jackson, Mississippi
Mount Sinai Medical Center
Miami, Florida
Arizona Heart Institute
Phoenix, Arizona
Wheaton Franciscan Healthcare
Racine, Wisconsin
Rex Health
Raleigh, North Carolina
Desert Cardiology
Rancho Mirage, California
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Above the Knee | Patients treated with the Chocolate balloon for a lesion located above the knee | |
| Below the Knee | Patients treated with the Chocolate balloon for a lesion located below the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Optimal PTA
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting
Measured: average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriReme Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihad Mustapha, MD, Principal investigator, Metro Health HospitalLawrence Garcia, MD, Principal investigator, St Elizabeth's Med Center / Tufts Univ School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589042
- Sponsor's protocol ID
- CLP782
- Acronym
- Chocolate BAR
- Status last verified
- Sep 2018
- First submitted
- 27 Apr 2012
- 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
- Chocolate Balloon Angioplasty Registry
- ClinicalTrials.gov ID
- NCT01589042
- Acronym / sponsor ID
- Chocolate BAR / CLP782
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- TriReme Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 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.
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Above the Knee | – | –Patients treated with the Chocolate balloon for a lesion located above the knee |
| Below the Knee | – | –Patients treated with the Chocolate balloon for a lesion located below the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty
Key inclusion criteria (4 listed)
- >18 years of age
- Lesion successfully crossed with a guide-wire
- Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
- Patient has given consent for their information to be submitted to this registry
Key exclusion criteria (3 listed)
- Lesion required stenting as the primary treatment approach
- Life expectancy <12 months
- Patient is enrolled in another clinical study that may impact the results of 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.
Primary outcome
Achievement of Optimal PTA
Time frame: average of 2 hours
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting
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.
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Peripheral Arterial 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.
Jihad Mustapha, MD principal investigator
Metro Health Hospital
Lawrence Garcia, MD principal investigator
St Elizabeth's Med Center / Tufts Univ School of Medicine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by TriReme Medical, LLC at 13 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 4 inclusion and 3 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 13 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?
Achievement of Optimal PTA (time frame: average of 2 hours). 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.