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

Fudan University

Status: Not yet enrolling

Conditions: Coronary Calcification

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07277114

KY2025283

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 656 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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656 participants in 2 patient groups

Drug coated balloon

Experimental group

Description:

Drug coated balloon treatment after optimal calcium modification assessed by QFR

Treatment:

Device: Intravascular Lithotripsy (IVL)

Device: rotational atherectomy (RA)

Device: excimer laser coronary angioplasty (ELCA)

Drug eluting stent

Active Comparator group

Description:

Drug eluting stent treatment after optimal calcium modification assessed by QFR

Treatment:

Device: Intravascular Lithotripsy (IVL)

Device: rotational atherectomy (RA)

Device: excimer laser coronary angioplasty (ELCA)