Coronary Artery DiseaseNCT07559903
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
An observational study of Coronary Artery Disease, run by Emory University at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 5,000 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 1 Jul 2026to May 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are patients undergoing standard-of-care DCB PCI for de novo CAD at participating sites. Eligibility will be determined by trained research personnel via a review of the EMR to ensure patients meet the inclusion criteria.
Who may be able to join
- All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB
Who cannot join
- Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions
Trial locations and contacts
19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 3 countries
United States17 sites, 17 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Imran Aslam
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kevin Croce
- Not yet recruiting
Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
Nyal Borges
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Bernardo Cortese
- Not yet recruiting
Duke University Hospital
Durham, North Carolina, 27707
Mariem Sawan
- Not yet recruiting
Holy Cross Health Fort Lauderdale
Fort Lauderdale, Florida, 33308
Josh Purow, MD
Felipe Albuquerque, MD
- Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
- Not yet recruiting
Allina Health Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Manos Brilakis
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Leah Raj
- Not yet recruiting
The Mount Sinai Hospital
New York, New York, 10029
Shamin Sharma
- Not yet recruiting
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Jai Khatri
- Not yet recruiting
Montefiore Medical Center
New York, New York, 10467
Azeem Latib
Louis Verreault-Julien
- Not yet recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
- Not yet recruiting
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
Ziad Ali
Germany1 site, 1 recruiting
- Not yet recruiting
Universitatsklinikum des Saarlandes
Homberg (Efze)
Bruno Scheller
Serbia1 site, 1 recruiting
- Not yet recruiting
University Clinical Centre of Serbia
Belgrade
Goran Stankovic
About this study
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.
Read the detailed description
This database is designed as a prospective, international multi-center registry. The project aims to collect longitudinal data to evaluate the clinical performance of drug-coated balloons (DCB) in adult patients undergoing percutaneous coronary intervention (PCI) for de novo coronary artery disease. Emory will serve as the data coordinating center. All the participating sites will input information into Emory-hosted Redcap database. Data use agreements will be executed between Emory and each participating institution prior to data entry.
As a prospective registry, all clinical interventions, including the choice of DCB, vessel preparation techniques, and adjunct pharmacotherapy, are performed at the discretion of the treating physician according to the standard of care; no experimental interventions are mandated by this protocol.
- Conditions
- Coronary Artery Disease
- Keywords
- Drug coated balloon, Percutaneous coronary intervention, Target lesion failure
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Target Lesion Failure (TLF)
Incidence of Target Lesion Failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR) will be documented.
Measured: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Mortality and Myocardial Infarction
Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.
Measured: 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
Frequency of any repeat revascularization, specifically focusing on clinically driven TLR and clinically driven target vessel revascularization (TVR) will be assessed.
Measured: 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
The incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosis according to Academic Research Consortium (ARC) definitions will be documented.
Measured: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Number of bleeding events
The safety profile of post-procedural pharmacotherapy will be evaluated through the collection of bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria.
Measured: At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jul 2026
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pratik Sandesara, Emory University
- Investigators
- Pratik Sandesara, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559903
- Sponsor's protocol ID
- 2026P000463
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data will be shared between sites. All clinical data will be shared including demographics, clinical characteristics, procedural characteristics, and outcomes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
- ClinicalTrials.gov ID
- NCT07559903
- Acronym / sponsor ID
- 2026P000463
- Conditions
- Coronary Artery Disease
- Keywords
- Drug coated balloon, Percutaneous coronary intervention, Target lesion failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This database is designed as a prospective, international multi-center registry. The project aims to collect longitudinal data to evaluate the clinical performance of drug-coated balloons (DCB) in adult patients undergoing percutaneous coronary intervention (PCI) for de novo coronary artery disease. Emory will serve as the data coordinating center. All the participating sites will input information into Emory-hosted Redcap database. Data use agreements will be executed between Emory and each participating institution prior to data entry.
As a prospective registry, all clinical interventions, including the choice of DCB, vessel preparation techniques, and adjunct pharmacotherapy, are performed at the discretion of the treating physician according to the standard of care; no experimental interventions are mandated by this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are patients undergoing standard-of-care DCB PCI for de novo CAD at participating sites. Eligibility will be determined by trained research personnel via a review of the EMR to ensure patients meet the inclusion criteria.
Key inclusion criteria (1 listed)
- All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB
Key exclusion criteria (1 listed)
- Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Incidence of Target Lesion Failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR) will be documented.
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
Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.
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
Frequency of any repeat revascularization, specifically focusing on clinically driven TLR and clinically driven target vessel revascularization (TVR) will be assessed.
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
The incidence of Target Vessel Failure (TVF) and definite/probable vessel thrombosis according to Academic Research Consortium (ARC) definitions will be documented.
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
The safety profile of post-procedural pharmacotherapy will be evaluated through the collection of bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data will be shared between sites. All clinical data will be shared including demographics, clinical characteristics, procedural characteristics, and outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pratik Sandesara, MD principal investigator
Emory University
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Emory University at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Gold, MD (314-761-3396, daniel.alexander.gold@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.