Recruiting

DCB

Sponsor:

Emory University

Code:

NCT07559903

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Coronary Artery Disease

Study ID

NCT07559903

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB

Exclusion Criteria:

  • Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 ]
  • Mortality and Myocardial Infarction [ Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge ]
  • Number of any repeat Revascularization [ Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge ]
  • Incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosis [ Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge ]
  • Number of bleeding events [ Time Frame: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge ]

Central Contacts and Locations

Central contacts

Daniel Gold, MD

314-761-3396daniel.alexander.gold@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Emory Johns Creek Hospital

Recruiting

Johns Creek, Georgia, United States, 30097

More Information

Sponsor

Emory University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Drug coated balloon
  • Percutaneous coronary intervention
  • Target lesion failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-15.