Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)

NCT05447585 | Unknown

• 1 other identifier: AMD-D-001
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcification of Coronary Artery

Keywords

calcification, coronary artery

Outcome Measures

Primary Outcomes (2)

• FIM phase: Clinical success

  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).

  During hospitalization (up to 7 days after baseline procedure).

• RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)

  MACE is composed of cardiac death, myocardial infarction and target vessel revascularization.

  30 days after baseline procedure.

Secondary Outcomes (3)

• Device success

  Baseline procedure

• Procedural success

  Baseline procedure

• Procedure-related complications

  Baseline procedure

Study Arms (2)

Coronary Atherectomy System

EXPERIMENTAL

Subjects in experimental arm will be treated with the Coronary Atherectomy System manufactured by Shanghai Microport Rhythm Co. Ltd.

Device: Coronary atherectomy system of Shanghai MicroPort Rhythm

Rotablator Rotational Atherectomy System

ACTIVE COMPARATOR

Subjects in control arm will be treated with Rotablator Rotational Atherectomy System manufactured by Boston Scientific Corporation

Device: Rotablator Rotational Atherectomy System

Interventions

Coronary atherectomy system of Shanghai MicroPort Rhythm DEVICE

Coronary Atherectomy System utilizes a diamond-coated eccentric crown to expand the lumen diameter via centrifugal forces while rotating over an atherectomy guide wire.

Also known as: Stenting will be applied in both arms

Coronary Atherectomy System

Rotablator Rotational Atherectomy System DEVICE

The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console

Also known as: Stenting will be applied in both arms

Rotablator Rotational Atherectomy System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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, .

You may not qualify if:

• 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%).
• 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.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jianan Wang, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 7, 2022
• Study Start: July 1, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

CN (1)