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Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)

Primary Purpose

Calcification of Coronary Artery

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Coronary atherectomy system of Shanghai MicroPort Rhythm
Rotablator Rotational Atherectomy System
Sponsored by
Shanghai MicroPort Rhythm MedTech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcification of Coronary Artery focused on measuring calcification, coronary artery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Exclusion Criteria:

AE1. Target lesions that meet the following criteria:

  • Ostial lesions (within 5mm of ostium);
  • Target lesions involve bifurcation lesions, and branch vessels need to be implanted with stents;
  • Angular lesions (> 45 °)
  • Located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass;
  • Thrombosis in the target vessel;
  • Target lesion dissection;
  • In-stent restenosis;
  • Chronic total occlusion lesions that cannot be passed through by atherectomy guidewire.

AE2. Unprotected left main coronary artery disease (> 50% diameter stenosis).

AE3. Protected left main coronary artery disease (> 50% diameter stenosis at LMCA and left coronary artery receive bypass grafting), and the target lesion is located in LAD or LCX.

AE4. Other clinical significant lesions in target vessels may require intervention within 2 months after baseline surgery.

AE5. The target vessel (including collateral) near the target lesion or within 10 mm (visually) from the distal end of the target lesion has received stent implantation at any time before baseline surgery.

AE6. Especially tortuous target vessels. AE7. Non-target lesion failed to be treated before the treatment of target lesion.

Sites / Locations

  • The Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coronary Atherectomy System

Rotablator Rotational Atherectomy System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
MACE is composed of cardiac death, myocardial infarction and target vessel revascularization.

Secondary Outcome Measures

Device success
Device success is defined as successful stent delivery after atherectomy and without periprocedural complications
Procedural success
Procedural success was defined as successful stent delivery with <50% residual stenosis and TIMI flow III and without periprocedural complications
Procedure-related complications
Procedure-related complications are defined as severe dissection (Type D to F), perforation, stent upload and in-stent thrombosis.

Full Information

First Posted
June 16, 2022
Last Updated
August 4, 2022
Sponsor
Shanghai MicroPort Rhythm MedTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05447585
Brief Title
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
Official Title
A Prospective, Multicenter Clinical Trial of Coronary Atherectomy System in Patients With Calcified Coronary Artery Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Rhythm MedTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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. 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. 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. All subjects receive clinical follow-up during hospitalization and 30 days, 6 months and 12 months after surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcification of Coronary Artery
Keywords
calcification, coronary artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
239 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary Atherectomy System
Arm Type
Experimental
Arm Description
Subjects in experimental arm will be treated with the Coronary Atherectomy System manufactured by Shanghai Microport Rhythm Co. Ltd.
Arm Title
Rotablator Rotational Atherectomy System
Arm Type
Active Comparator
Arm Description
Subjects in control arm will be treated with Rotablator Rotational Atherectomy System manufactured by Boston Scientific Corporation
Intervention Type
Device
Intervention Name(s)
Coronary atherectomy system of Shanghai MicroPort Rhythm
Other Intervention Name(s)
Stenting will be applied in both arms
Intervention Description
Coronary Atherectomy System utilizes a diamond-coated eccentric crown to expand the lumen diameter via centrifugal forces while rotating over an atherectomy guide wire.
Intervention Type
Device
Intervention Name(s)
Rotablator Rotational Atherectomy System
Other Intervention Name(s)
Stenting will be applied in both arms
Intervention Description
The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
Primary Outcome Measure Information:
Title
FIM phase: Clinical success
Description
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).
Time Frame
During hospitalization (up to 7 days after baseline procedure).
Title
RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
Description
MACE is composed of cardiac death, myocardial infarction and target vessel revascularization.
Time Frame
30 days after baseline procedure.
Secondary Outcome Measure Information:
Title
Device success
Description
Device success is defined as successful stent delivery after atherectomy and without periprocedural complications
Time Frame
Baseline procedure
Title
Procedural success
Description
Procedural success was defined as successful stent delivery with <50% residual stenosis and TIMI flow III and without periprocedural complications
Time Frame
Baseline procedure
Title
Procedure-related complications
Description
Procedure-related complications are defined as severe dissection (Type D to F), perforation, stent upload and in-stent thrombosis.
Time Frame
Baseline procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria: AE1. Target lesions that meet the following criteria: Ostial lesions (within 5mm of ostium); Target lesions involve bifurcation lesions, and branch vessels need to be implanted with stents; Angular lesions (> 45 °) Located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass; Thrombosis in the target vessel; Target lesion dissection; In-stent restenosis; Chronic total occlusion lesions that cannot be passed through by atherectomy guidewire. AE2. Unprotected left main coronary artery disease (> 50% diameter stenosis). AE3. Protected left main coronary artery disease (> 50% diameter stenosis at LMCA and left coronary artery receive bypass grafting), and the target lesion is located in LAD or LCX. AE4. Other clinical significant lesions in target vessels may require intervention within 2 months after baseline surgery. AE5. The target vessel (including collateral) near the target lesion or within 10 mm (visually) from the distal end of the target lesion has received stent implantation at any time before baseline surgery. AE6. Especially tortuous target vessels. AE7. Non-target lesion failed to be treated before the treatment of target lesion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, M.D.
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

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Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)

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