ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Emory University
- Study ID
- NCT07559903
- Status
- Recruiting
Conditions
- Coronary Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.
Key Dates
- First listed
- Apr 30, 2026
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- May 31, 2031
- Completion
- May 31, 2031
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Adults undergoing PCI with drug-coated balloons (DCB) for de novo coronary artery diseaseAll adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.
Primary Outcome Measure
Incidence of Target Lesion Failure (TLF) [ Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge ]
Central Contacts
- Daniel Gold, MD314-761-3396
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | - |
| Holy Cross Health Fort Lauderdale | Fort Lauderdale | Florida | 33308 | Josh Purow, MD Felipe Albuquerque, MD (SUB_INVESTIGATOR) |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | - |
| Emory University Hospital | Atlanta | Georgia | 30322 | - |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | - |
| Emory Johns Creek Hospital | Johns Creek | Georgia | 30097 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Kevin Croce |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Imran Aslam |
| Allina Health Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | Manos Brilakis |
| Montefiore Medical Center | New York | New York | 10467 | Azeem Latib Louis Verreault-Julien (SUB_INVESTIGATOR) Pier Pasquale Leone (SUB_INVESTIGATOR) |
| New York-Presbyterian/Weill Cornell Medical Center | New York | New York | 10065 | Jai Khatri |
| The Mount Sinai Hospital | New York | New York | 10029 | Shamin Sharma |
| St. Francis Hospital & Heart Center | Roslyn | New York | 11576 | Ziad Ali |
| Sanger Heart & Vascular Institute | Charlotte | North Carolina | 28203 | Nyal Borges |
| Duke University Hospital | Durham | North Carolina | 27707 | Mariem Sawan |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Bernardo Cortese |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Leah Raj |
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