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
Not Yet Recruiting

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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

Start date
May 31, 2026
Status verified
Apr 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 disease
    All 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

Locations (16)

FacilityCityStateZIPSite coordinators
Banner University Medical CenterPhoenixArizona85006-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University HospitalAtlantaGeorgia30322-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory Johns Creek HospitalJohns CreekGeorgia30097-
Brigham and Women's HospitalBostonMassachusetts02115
Kevin Croce
Tufts Medical CenterBostonMassachusetts02111
Imran Aslam
Allina Health Minneapolis Heart InstituteMinneapolisMinnesota55407
Manos Brilakis
Montefiore Medical CenterNew YorkNew York10467
Azeem Latib
Louis Verreault-Julien (SUB_INVESTIGATOR)
Pier Pasquale Leone (SUB_INVESTIGATOR)
New York-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10065
Jai Khatri
The Mount Sinai HospitalNew YorkNew York10029
Shamin Sharma
St. Francis Hospital & Heart CenterRoslynNew York11576
Ziad Ali
Sanger Heart & Vascular InstituteCharlotteNorth Carolina28203
Nyal Borges
Duke University HospitalDurhamNorth Carolina27707
Mariem Sawan
University Hospitals Cleveland Medical CenterClevelandOhio44106
Bernardo Cortese
Vanderbilt University Medical CenterNashvilleTennessee37232
Leah Raj

Find similar trials in Phoenix, AZ

By research site
Banner University Medical Center· Phoenix, AZEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory Johns Creek Hospital· Johns Creek, GABrigham and Women's Hospital· Boston, MA

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