ClinicalTrials.gg
CompletedNCT01589042Chocolate BARUpdated Sep 11, 2018

Chocolate Balloon Angioplasty Registry

An observational study in Peripheral Arterial Disease, sponsored by TriReme Medical, LLC. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by TriReme Medical, LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
490
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's enrollment of 490 is above the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

TriReme Medical, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. >18 years of age
  2. Lesion successfully crossed with a guide-wire
  3. Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
  4. Patient has given consent for their information to be submitted to this registry

Exclusion criteria

Exclusion Criteria:

  1. Lesion required stenting as the primary treatment approach
  2. Life expectancy \<12 months
  3. Patient is enrolled in another clinical study that may impact the results of this registry
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
490 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: average of 2 hours

07

Study locations

13 sites
  • Arizona Heart Institute
    Phoenix, Arizona, United States
  • Desert Cardiology
    Rancho Mirage, California, United States
  • Cardiovascular Research of North Florida
    Gainesville, Florida, United States
  • Mount Sinai Medical Center
    Miami, Florida, United States
  • Alexian Brothers Heart and Vascular
    Elk Grove Village, Illinois, United States
  • St. Elizabeth's Medical Center
    Boston, Massachusetts 02135, United States
  • St. John's Hospital
    Detroit, Michigan, United States
  • Metro Health Hospital
    Wyoming, Michigan 49519, United States
  • Jackson Heart Clinic
    Jackson, Mississippi, United States
  • Rex Health
    Raleigh, North Carolina, United States
  • Cardiovascular Research of Dallas
    Dallas, Texas, United States
  • VA North Texas
    Dallas, Texas, United States
  • Wheaton Franciscan Healthcare
    Racine, Wisconsin, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01589042
Lead sponsor
TriReme Medical, LLC
Responsible party
Sponsor
First posted
May 1, 2012
Start date
May 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Sep 11, 2018

Study contacts

Jihad Mustapha, MD
principal investigator · Metro Health Hospital
Lawrence Garcia, MD
principal investigator · St Elizabeth's Med Center / Tufts Univ School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion