Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Tenth People's Hospital affiliated to Tongji University | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug coated balloon | Experimental | Drug coated balloon treatment after optimal calcium modification assessed by QFR |
|
| Drug eluting stent | Active Comparator | Drug eluting stent treatment after optimal calcium modification assessed by QFR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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).
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.
â‘¥ 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.
â‘§ 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.
â‘© Patients currently participating in another clinical trial for coronary interventional devices.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianying Ma | Contact | +86-64041990-5115 | ma.jianying@zs-hospital.sh.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101114 | Result | 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. | |
| 36847902 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017225 | Atherectomy, Coronary |
| ID | Term |
|---|---|
| D017073 | Atherectomy |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
|
| one year after treatment |
| 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. |
| 32789835 | 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. |
| 32553329 | 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. |
| D009204 |
| Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |