DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR

NCT07277114 | Recruiting

• 1 other identifier: KY2025283
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:

1. 1.Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).
2. 2.Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
3. 3.Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.

Conditions

Coronary Calcification

Keywords

coronary calcification; Drug coated balloon; quantitative flow reserve

Outcome Measures

Primary Outcomes (1)

• Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.

  One year after treatement.

Secondary Outcomes (2)

• Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.

  From treatment to hospital discharge

• QFR at one year post PCI

  one year after treatment

Study Arms (2)

Drug coated balloon

EXPERIMENTAL

Drug coated balloon treatment after optimal calcium modification assessed by QFR

Device: rotational atherectomy (RA); Device: excimer laser coronary angioplasty (ELCA); Device: Intravascular Lithotripsy (IVL)

Drug eluting stent

ACTIVE COMPARATOR

Drug eluting stent treatment after optimal calcium modification assessed by QFR

Device: rotational atherectomy (RA); Device: excimer laser coronary angioplasty (ELCA); Device: Intravascular Lithotripsy (IVL)

Interventions

rotational atherectomy (RA) DEVICE

Rotational atherectomy (RA) is a procedure that uses a diamond-coated, high-speed rotating burr to shave and remove calcified plaque from coronary arteries

Drug coated balloon; Drug eluting stent

Intravascular Lithotripsy (IVL) DEVICE

An IVL catheter with emitters is inserted into the artery, and it delivers pulsatile shock waves to crack the calcium, which then allows for a balloon or stent to be safely expanded to restore blood flow.

Drug coated balloon; Drug eluting stent

excimer laser coronary angioplasty (ELCA) DEVICE

Excimer laser coronary angioplasty (ELCA) is a minimally invasive procedure that uses pulses of ultraviolet light to vaporize plaque in a blocked coronary artery. The procedure involves inserting a catheter with a laser fiber optic tip into an artery in the groin or arm, guiding it to the blockage using X-ray guidance, and then using the laser to ablate the plaque and improve blood flow.

Drug coated balloon; Drug eluting stent

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Moderate to severe calcified lesions assessed by coronary angiography
• In situ coronary artery calcification
• Target lesion with indications for coronary intervention
• Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm
• Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).
• QFR \> 0.8 after calcification modification

You may not qualify if:

• Patients with ST-segment elevation myocardial infarction:
• Patients with renal failure requiring dialysis or currently undergoing dialysis.
• Patients whose coronary angiography quality is unsuitable for QFR analysis.
• Patients with in-stent restenosis.
• ⑤ Patients with other medical conditions and a life expectancy of \<1 year.
• ⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.
• ⑦ Patients who cannot tolerate dual antiplatelet therapy.
• ⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.
• ⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.
• ⑩ Patients currently participating in another clinical trial for coronary interventional devices.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Tenth People's Hospital affiliated to Tongji University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (4)

• Joh HS, Kwon W, Shin D, Lee SH, Hong YJ, Hong D, Lee SY, Park H, Kim S, Lee SY, Koh JS, Kim H, Kim CJ, Choo EH, Yoon HJ, Park SD, Jeon KH, Bae JW, Ahn SG, Kim SE, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia. 2024 Jun 18;4(7):519-531. doi: 10.1016/j.jacasi.2024.04.007. eCollection 2024 Jul.

  PMID: 39101114 RESULT

• Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.

  PMID: 36847902 RESULT

• Shin ES, Bang LH, Jun EJ, Her AY, Chung JH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK, Tang Q. Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion. Cardiol J. 2021;28(4):615-622. doi: 10.5603/CJ.a2020.0105. Epub 2020 Aug 13.

  PMID: 32789835 RESULT

• Guedeney P, Claessen BE, Mehran R, Mintz GS, Liu M, Sorrentino S, Giustino G, Farhan S, Leon MB, Serruys PW, Smits PC, von Birgelen C, Ali ZA, Genereux P, Redfors B, Madhavan MV, Ben-Yehuda O, Stone GW. Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053.

  PMID: 32553329 RESULT

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

Jianying Ma

CONTACT

+86-64041990-5115; ma.jianying@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine/Cardiology and Director of the Department of Cardiology at Zhongshan Hospital, Fudan University,Chairman of the Shanghai Institute of Cardiovascular Diseases.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CN (1)