NCT07852689Not yet recruiting
Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies
Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB): A Multicenter, Prospective, Randomized Controlled, Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion). The main questions are: 1. Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery. 2. Does the DCB-based strategy reduce the number and total length of stents implanted? 3. What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up? Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable result; a DES may be implanted if needed to achieve a safe and adequate result. In the DES-only group, the lesion will be treated with a DES. Participants will: 1. Receive treatment according to their assigned strategy. 2. Undergo follow-up coronary angiography and FFR measurement at approximately 6 months. For clinical reasons, this examination may take place up to 9 months after the procedure. 3. Be followed for cardiovascular events through 12 months after randomization.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Korea University Guro Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07852689
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Nov 2026 to the primary completion date, Sept 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active bleeding, a clinically significant bleeding tendency, or a coagulation disorder.
- Hypersensitivity or a contraindication to aspirin, P2Y12 inhibitors, or components of a DES or DCB (drug, polymer, or metal).
- Angiographic exclusion:
- Target lesion in ISR (in-stent restenosis).
- Target lesion in a bypass graft.
- Chronic total occlusion
- Left main coronary artery disease.
- History of stent thrombosis.
- Expected survival of less than 1 year because of comorbid illness.
Lab values
- Left ventricular ejection fraction ≤20%.
Other
- Refractory cardiogenic shock.
- Pregnancy or breastfeeding.
- In the investigator's judgment, unsuitable for study participation for clinical or anatomical reasons.
Who the study is looking for
- Adults aged 19 years or older.
- Patients requiring coronary revascularization for angina or myocardial infarction.
- A target or culprit lesion suitable for both DCB and DES treatment.
- Reference vessel diameter of the target or culprit lesion ≥2.25 mm.
- Voluntary written informed consent after an explanation of the study objectives and procedures.
- For foreign nationals, ability to communicate in Korean.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hanil General Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.