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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-12-31

Brief Summary

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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. 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. Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
3. Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.

Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR \>0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.

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Detailed Description

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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.

Definite or probable thrombosis in DCB or DES treated vessels will be documented.

After randomization, if a dissection with restricted blood flow occurs after DCB treatment, DES will be implanted.

Conditions

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Coronary Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug coated balloon

Drug coated balloon treatment after optimal calcium modification assessed by QFR

Group Type EXPERIMENTAL

excimer laser coronary angioplasty (ELCA)

Intervention Type 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.

Intravascular Lithotripsy (IVL)

Intervention Type 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.

rotational atherectomy (RA)

Intervention Type 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 eluting stent

Drug eluting stent treatment after optimal calcium modification assessed by QFR

Group Type ACTIVE_COMPARATOR

excimer laser coronary angioplasty (ELCA)

Intervention Type 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.

Intravascular Lithotripsy (IVL)

Intervention Type 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.

rotational atherectomy (RA)

Intervention Type 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

Interventions

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excimer laser coronary angioplasty (ELCA)

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.

Intervention Type DEVICE

Intravascular Lithotripsy (IVL)

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.

Intervention Type DEVICE

rotational atherectomy (RA)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Junbo Ge

Professor of Medicine/Cardiology and Director of the Department of Cardiology at Zhongshan Hospital, Fudan University,Chairman of the Shanghai Institute of Cardiovascular Diseases.

Responsibility Role PRINCIPAL_INVESTIGATOR