Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions

NCT07548281 | Not Yet Recruiting

• 1 other identifier: 2026-0258
• Study Type: interventional
• Target: 2,492
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trial name Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions Objectives To compare the safety and efficacy of Drug-Coated Balloons (DCB) versus Drug-Eluting Stents (DES) in large de novo coronary lesions guided by intravascular ultrasound (IVUS) and Angiography-derived fractional flow reserve (AngioFFR). Study design Investigator-initiated, open-label, multicenter, non-inferiority randomized controlled trial Patient enrollment 2,492 patients enrolled in China and Republic of Korea. Duration Anticipated recruitment is 2 years. Follow-up will be performed at 1, 3, 6, 12, 36, and 60 months. Inclusion Criteria

1. 1.Patients must require PCI based on clinical condition (angiographic stenosis ≥ 75% or angiographic stenosis ≥ 50% with AngioFFR≤0.80) and have signed the informed consent form.
2. 2.Coronary angiography shows a single non-left main lesion, with a reference vessel diameter between 2.75mm and 4.00mm, and an estimated lesion length \< 40mm.
3. 3.Following adequate intraoperative lesion preparation, the following must be met: IVUS shows MLA≥ 4.0mm² and/or AnioFFR \> 0.80.
4. 4.Absence of flow-limiting dissection or hematoma (angiographic Type A or B dissection; IVUS dissection not involving the media) and TIMI flow grade 3
5. 5.Patients must be able to be followed up for more than 1 year and be willing to cooperate with the trial follow-up requirements.
6. 6.Patients are younger than 19 or older than 80 years of age.
7. 7.High-Risk Clinical/Anatomical Factors: Cardiogenic shock, left main disease, severely tortuous lesions, complex bifurcation lesions, severe calcification, total occlusion of the target vessel, or bypass grafts.
8. 8.Recent major surgery (within 1 month pre-procedure) or clear gastrointestinal bleeding events.
9. 9.Known allergy or contraindication to heparin, aspirin, clopidogrel, prasugrel, ticagrelor, or contrast media (patients with clear contrast allergies such as rash may be included if controlled beforehand with effective medication like glucocorticoids or diphenhydramine).
10. 10.Women who are currently pregnant or breastfeeding.
11. 11.Non-cardiac comorbidities indicating an expected life expectancy of less than 1 year.
12. 12.Any other factors that may affect follow-up or participation in other clinical studies.
13. 13.Target Vessel Failure (TVF): A composite of cardiac death, target vessel MI, or target vessel revascularization.
14. 14.NACE, major bleeding or clinically relevant non-major bleeding, and MACCE at 36 and 60 months.
15. 15.All-cause death and cardiac death.
16. 16.MI, spontaneous MI, peri-procedural MI, and target vessel MI.
17. 17.Any revascularization of the target vessel/target lesion.
18. 18.Any revascularization of a non-target vessel/ non-target lesion.
19. 19.Any revascularization (ischemia-driven or all-cause).
20. 20.Stent Thrombosis: Classified as definite, probable, or possible.
21. 21.Stroke: Including both ischemic and hemorrhagic stroke.
22. 22.Bleeding Events: BARC 3 or 5 bleeding, and BARC 2 bleeding.
23. 23.Evaluation of cost-effectiveness.

Conditions

Coronary Artery Disease

Keywords

Drug-coated balloon; De novo large vessel lesion; Intravascular ultrasound; Angiography-derived fractional flow reserve; Percutaneous coronary intervention; coronary artery disease

Outcome Measures

Primary Outcomes (3)

• Net Adverse Clinical Events (NACE)

  Cumulative incidence of death, stroke, myocardial infarction (MI), ischemia-driven revascularization, or bleeding (BARC 3 or 5). Scale: %

  12 months after the procedure

• Ischemic Endpoint - Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  Cumulative incidence of death, MI, ischemia-driven revascularization, or ischemic stroke. Scale: %

  12 months after the procedure

• Bleeding Endpoint

  Cumulative incidence of major bleeding or clinically relevant non-major bleeding, categorized as BARC 2, 3, or 5. Scale: %

  12 months after the procedure

Secondary Outcomes (10)

• Net Adverse Clinical Events (NACE)

  36 and 60 months after the procedure

• 2. Ischemic Endpoint - Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  36, 60 months after the procedure

• Bleeding Events

  36, 60 months after the procedure

• Target Vessel Failure (TVF)

  12, 36, 60 months after the procedure

• All-cause death and cardiac death

  12, 36, 60 months after the procedure

Study Arms (2)

DCB Treatment Group

EXPERIMENTAL

Drug-Coated Balloons (DCB) in large de novo coronary lesions

Device: DCB in large de novo coronary lesions guided by IVUS and AngioFFR

DES Treatment Group

ACTIVE COMPARATOR

Drug-Eluting Stents (DES) in large de novo coronary lesions

Device: DES in large de novo coronary lesions guided by IVUS and AngioFFR

Interventions

DCB in large de novo coronary lesions guided by IVUS and AngioFFR DEVICE

Visual reference vessel diameter of 2.75 mm to 4 mm. Lesion pre-treatment: Adequate pre-treatment of the lesion was performed (including use of semi-compliant / non-compliant balloons or specialty balloons). Imaging and functional assessment: After pre-treatment, the lesion met the following physiological and anatomical requirements: IVUS: MLA ≥ 4.0 mm²; And/or AngioFFR \> 0.80. No flow-limiting dissection, defined as: Coronary angiography: Only type A or type B dissection present; IVUS: Dissection not involving the vascular media; Coronary flow: TIMI flow grade 3 maintained. * Patients receive DAPT for 1 month. * After 1 month, therapy is switched to SAPT, with Clopidogrel as the preferred agent. * Oral Anticoagulants: If the patient is concurrently taking oral anticoagulants, they will receive SAPT plus anticoagulation for 1 month, followed by anticoagulation alone.

DCB Treatment Group

DES in large de novo coronary lesions guided by IVUS and AngioFFR DEVICE

Visual reference vessel diameter of 2.75 mm to 4 mm. Lesion pre-treatment: Adequate pre-treatment of the lesion was performed (including use of semi-compliant / non-compliant balloons or specialty balloons). Imaging and functional assessment: After pre-treatment, the lesion met the following physiological and anatomical requirements: IVUS: MLA ≥ 4.0 mm²; And/or AngioFFR \> 0.80. No flow-limiting dissection, defined as: Coronary angiography: Only type A or type B dissection present; IVUS: Dissection not involving the vascular media; Coronary flow: TIMI flow grade 3 maintained. * Patients receive DAPT for at least 6 months following DES implantation. * Subsequent antiplatelet regimens are determined by the operator's discretion. * Oral Anticoagulants: If the patient is concurrently taking oral anticoagulants, they will receive DAPT plus anticoagulation for 1 month, followed by SAPT plus anticoagulation. DCB or DES Used in PCI.

DES Treatment Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must require PCI based on clinical condition (angiographic stenosis ≥ 75% or angiographic stenosis ≥ 50% with AngioFFR≤0.80) and have signed the informed consent form.
• Coronary angiography shows a single non-left main lesion, with a reference vessel diameter between 2.75mm and 4.00mm, and an estimated lesion length \< 40mm.
• Following adequate intraoperative lesion preparation, the following must be met: IVUS shows MLA≥ 4.0mm² and/or AnioFFR \> 0.80.
• Absence of flow-limiting dissection or hematoma (angiographic Type A or B dissection; IVUS dissection not involving the media) and TIMI flow grade 3
• Patients must be able to be followed up for more than 1 year and be willing to cooperate with the trial follow-up requirements.

You may not qualify if:

• Patients younger than 19 or older than 80 years of age.
• High-Risk Clinical/Anatomical Factors: Cardiogenic shock, left main disease, severely tortuous lesions, complex bifurcation lesions, severe calcification, total occlusion of the target vessel, or bypass grafts.
• Recent major surgery (within 1 month pre-procedure) or clear gastrointestinal bleeding events.
• Known allergy or contraindication to heparin, aspirin, clopidogrel, prasugrel, ticagrelor, or contrast media (patients with clear contrast allergies such as rash may be included if controlled beforehand with effective medication like glucocorticoids or diphenhydramine).
• Women who are currently pregnant or breastfeeding.
• Non-cardiac comorbidities indicating an expected life expectancy of less than 1 year.
• Any other factors that may affect follow-up or participation in other clinical studies.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Ulsan University Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• The First People's Hospital of Huzhou: collaborator
• Huzhou Central Hospital: collaborator
• First Affiliated Hospital of Ningbo University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Yiwu Central Hospital: collaborator
• People's Hospital of Quzhou: collaborator
• Lishui Country People's Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• First People's Hospital of Yulin: collaborator
• Longyan First Hospital, Affiliated to Fujian Medical University: collaborator
• Fourth Affiliated Hospital of Xinjiang Medical University: collaborator
• Shangrao People's Hospital: collaborator
• Fuyang people's hospital: collaborator
• First People's Hospital of Xianyang: collaborator
• The First People's Hospital of Yunnan: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jian Shen, MD,PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian'an Wang, MD,PhD

CONTACT

+86 0571-87783759; wangjianan111@zju.edu.cn

Jian Shen, MD,PhD

CONTACT

+86 0571-87783759; shenjian01@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 23, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): May 31, 2033
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available following primary article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to PIs.