Calcification of Coronary Artery
Conditions
Keywords
calcification, coronary artery
Brief summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
Detailed description
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single group observational test (FIM stage). The second phase is the pivotal study phase, which is a prospective, multicenter, randomized controlled and non inferiority test (RCT phase). It is carried out in about 25 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective, multicenter and single-arm observational test. It is expected to recruit 15 subjects in 3 to 5 research centers in China. The primary endpoint is procedural success rate. 2. Pivotal study phase (RCT phase): It is a prospective, multicenter, randomized controlled and non inferiority trial. 224 subjects are expected to be recruited in 25 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint of the RCT phase is the rate of no major adverse cardiovascular events (MACE) at 30 days after baseline. 3. All subjects with coronary calcified lesions participating in this clinical study must have a calcified lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.50 mm but ≤ 4.00 mm. 4. All subjects receive clinical follow-up during hospitalization and 30 days, 6 months and 12 months after surgery. 5. Successful enrollment: The atherectomy guidewires pass through the target lesion successfully (through the true lumen), and there are no vascular perforation, dissection, thrombosis and other complications.
Interventions
DEVICECoronary atherectomy system of Shanghai MicroPort Rhythm
Coronary Atherectomy System utilizes a diamond-coated eccentric crown to expand the lumen diameter via centrifugal forces while rotating over an atherectomy guide wire.
The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
Sponsors
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: CI1. Age between 18 and 80. CI2. Subjects who are going to accept percutaneous coronary intervention (PCI) and drug-eluting stent implantation. CI3. Asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction. CI4. Acceptable candidates for coronary artery bypass grafting (CABG). CI5. The left ventricular ejection fraction (LVEF) is equal to or greater than 30% measured by echocardiography or left ventricle contrast examination within 30 days before inclusion. CI6. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up. Angiography Inclusion Criteria: AI1. There is only one target lesion that needs to be treated. AI2. The target vessel must be a native coronary artery with reference diameter \>= 2.5mm and \<= 4.0 mm. AI3. The target vessel must be with a stenosis of \>= 70% and \< 100%Target lesion angiographic stenosis, or of \>=50% and \<70% with local ischemic symptoms. AI4. Target lesion length ≤ 40 mm . AI5. The target lesion must have evidence of severe calcium deposit, or moderate calcification which cannot be fully expanded by PTCA balloon catheter at the lesion site based on the protocol criterion, . Clinical
Exclusion criteria
CE1. Acute myocardial infarction within 30 days prior to baseline procedure. CE2. NYHA or Killip class III or IV heart failure. CE3. Severe cardiac insufficiency with reduced ejection fraction (left ventricular ejection fraction \< 30%). CE4. Intracardiac thrombus within 30 days before inclusion. CE5. Subjects who have received organ transplantation or is waiting for organ transplantation. CE6. Subjects who are receiving chemotherapy or scheduled to receive chemotherapy 30 days before or after baseline surgery. CE7. Subjects who are receiving chronic (≥ 72 hours) anticoagulant therapy (e.g. heparin, warfarin, coumarin) for indications other than acute coronary syndrome. CE8. Participants' platelet \< 50 × 10\^9 / L or \> 700 × 10\^9 / L, and / or hemoglobin \< 70g / L. CE9. Subjects with confirmed or suspected liver diseases, including active hepatitis, or abnormal laboratory results are not suitable for the study. CE10. Subjects diagnosed with chronic renal failure or has a serum creatinine level \>2.5 mg/dl (or 221 µmol / L). CE11. Subjects who have clear bleeding tendency, contraindications of antiplatelet preparation and anticoagulant treatment, and are unable to receive antithrombotic treatment. CE12. History of cerebrovascular accident (CVA), transient ischemic attack (TIA), active peptic ulcer disease, gastrointestinal (GI) bleeding, transient ischemic attack (TIA), or permanent neurological defects that may lead to non-compliance with the test protocol in the past 6 months. CE13. Target vessels (including collateral vessels) received any stent implantation within 12 months before baseline surgery. CE14. Non target vessels were treated with any type of PCI within 24 hours before baseline surgery. CE15. PCI or CABG is planned within 2 months after baseline procedure. CE16. History of coronary endovascular brachytherapy at any time. CE17. Known hypersensitivity to any drugs required by the stent or protocol (such as rapamycin or structure related compounds, fluoropolymers, aspirin or tigrelol, contrast medium, acrylic acid, stainless steel, chromium, nickel, iron, tungsten). CE18. Subjects who have other serious medical diseases (such as cancer, congestive heart failure), which may reduce life expectancy to less than 12 months or it is expected to be difficult to complete 12-months follow-up. CE19. Subjects who currently abuse drugs, such as heroin, alcohol, etc. CE20. Subjects who plan to undergo surgery that may lead to non-compliance with the protocol or confusion in data interpretation. CE21. Currently enrolled in any other clinical trial (does not reach its primary endpoint), or intended to participate in any other clinical trial within 12 months after baseline procedure. CE22. Females subjects who are pregnant,breast feeding or planning to become pregnant within the study period. CE23. Untrolled diabetes. CE24. Inability to understand the study or a history of non-compliance with medical advice. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIM phase: Clinical success | During hospitalization (up to 7 days after baseline procedure). | Clinical success is defined as successful stent delivery with a residual stenosis of \<50% and TIMI flow III without adverse events during procedure the occurrence of an in-hospital MACE (up to 7 days after surgery). |
| RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE) | 30 days after baseline procedure. | MACE is composed of cardiac death, myocardial infarction and target vessel revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Baseline procedure | Device success is defined as successful stent delivery after atherectomy and without periprocedural complications |
| Procedural success | Baseline procedure | Procedural success was defined as successful stent delivery with \<50% residual stenosis and TIMI flow III and without periprocedural complications |
| Procedure-related complications | Baseline procedure | Procedure-related complications are defined as severe dissection (Type D to F), perforation, stent upload and in-stent thrombosis. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJianan Wang, M.D.
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed