Peripheral Arterial Disease Clinical Trial
— Chocolate BAROfficial title:
Chocolate Balloon Angioplasty Registry
| NCT number | NCT01589042 |
| Other study ID # | CLP782 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | December 2015 |
| Verified date | September 2018 |
| Source | TriReme Medical, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 490 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | St. Elizabeth's Medical Center | Boston | Massachusetts |
| United States | Cardiovascular Research of Dallas | Dallas | Texas |
| United States | VA North Texas | Dallas | Texas |
| United States | St. John's Hospital | Detroit | Michigan |
| United States | Alexian Brothers Heart and Vascular | Elk Grove Village | Illinois |
| United States | Cardiovascular Research of North Florida | Gainesville | Florida |
| United States | Jackson Heart Clinic | Jackson | Mississippi |
| United States | Mount Sinai Medical Center | Miami | Florida |
| United States | Arizona Heart Institute | Phoenix | Arizona |
| United States | Wheaton Franciscan Healthcare | Racine | Wisconsin |
| United States | Rex Health | Raleigh | North Carolina |
| United States | Desert Cardiology | Rancho Mirage | California |
| United States | Metro Health Hospital | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| TriReme Medical, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | average of 2 hours |
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