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Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Primary Purpose

Patent Foramen Ovale, Cryptogenic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cera™ patent foramen ovale occluders
Another patent foramen ovale occluders
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Foramen Ovale

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18-60 years; Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent; Patent foramen ovale was confirmed by at least one of the following conditions exists: Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE); The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD); It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists: Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors; Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale; Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy; Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy. Exclusion Criteria: Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%); Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6 points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery blood supply area); Patients with intracardiac thrombosis or tumor, intracardiac vegetations; Acute myocardial infarction or unstable angina within 6 months; Left ventricular aneurysm formation or left ventricular wall movement disorder; Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery; Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure; Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm; Atrial fibrillation/atrial flutter (chronic or intermittent); Pregnant or planning to become pregnant during the trial; Patients with active endocarditis or other untreated infections or other hemorrhagic diseases; Pulmonary hypertension or patent foramen ovale was a special channel; Liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal value, serum creatinine (Cr) > 2 times the upper limit of normal value); Uncontrolled hypertension (> 180/100 mmHg); Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases; Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means; The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder; Thrombosis exists at the location or route of implantation; Malignant neoplasms or other diseases with a life expectancy of less than 2 years; Patients who could not be followed up during the trial; Participate in clinical trials of other drugs or medical devices within three months.

Sites / Locations

  • Peking University First Hospital
  • Fuwai Hospital ,CAMS&PUMC
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Meizhou people'HospitalRecruiting
  • The Second XiangYa Hospital of Central South UniversityRecruiting
  • The Third XiangYa Hospital of Central South UniversityRecruiting
  • The First Hospital Of JiLin Universitv
  • General Hospital of Northern Theater Command
  • Qilu Hospitalof Shandong University
  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
  • Fuwai Yunnan Cardiovascular HospitalRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Ningbo University
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cera™ patent foramen ovale occluders

Another patent foramen ovale occluders

Arm Description

Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).

Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).

Outcomes

Primary Outcome Measures

Success rate of effective occlusion
Effective occlusion was defined as: 180 days after the surgery, Transthoracic echocardiography (TTE) showed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast transthoracic echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.

Secondary Outcome Measures

Success rate of occluder implantation technology
The success of occluder implantation technology is defined as successful intraoperative implantation of occluder and immediate Echocardiography confirmed that the shape and position of the sealing device were appropriate, no new pericardial effusion or valve regurgitation was found, and the perioperative patients survived.
Success rate of surgical implantation of occlusion
Successful occluder implantation was defined as successful implantation of occluder and routine postoperative hospitalization that there were no serious adverse events related to surgery.
Success rate of complete occlusion
Complete occlusion was defined as the Transthoracic echocardiography (TTE) showing occlusion 180 days after surgery The position and shape of the apparatus were normal, and no horizontal atrial shunt was observed. The results of Contrast transthoracic echocardiography (cTTE) were reviewed there was no right-to-left shunt, that is, no microbubbles in the left heart cavity after Valsalva and resting state.
Success rate of effective occlusion
Success rate of effective occlusion was defined as: Transthoracic echocardiography (TTE) showed the position and shape of the occluder 360 days after the operation Normal condition, no horizontal atrial shunt; Reexamination by Contrast transthoracic echocardiography (cTTE) showed no or few results in other words, there were no microbubbles or less than 10 microbubbles in the left heart cavity after Valsalva and resting state.
Recurrence or incidence of cryptogenic stroke during follow-up
Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.
All-cause mortality rate
All-cause death is defined as death from any cause during the follow-up period.
Incidence of new atrial fibrillation and atrial flutter during follow-up period
atrial fibrillation and atrial flutter
Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)
Arterial embolism, Atrioventricular block III degree, heart abrasion, infective endocarditis, severe hemolytic anemia, etc.);
Incidence of device defects.
Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures.

Full Information

First Posted
February 26, 2023
Last Updated
August 31, 2023
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05774288
Brief Title
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Official Title
A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
Detailed Description
The purpose of this prospective, multi-center, randomized, controlled non-inferiority clinical trial was to evaluate the safety and efficacy of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale, Cryptogenic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-inferiority randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cera™ patent foramen ovale occluders
Arm Type
Experimental
Arm Description
Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Arm Title
Another patent foramen ovale occluders
Arm Type
Active Comparator
Arm Description
Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Intervention Type
Device
Intervention Name(s)
Cera™ patent foramen ovale occluders
Intervention Description
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Intervention Type
Device
Intervention Name(s)
Another patent foramen ovale occluders
Intervention Description
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Primary Outcome Measure Information:
Title
Success rate of effective occlusion
Description
Effective occlusion was defined as: 180 days after the surgery, Transthoracic echocardiography (TTE) showed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast transthoracic echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.
Time Frame
180 days after surgery
Secondary Outcome Measure Information:
Title
Success rate of occluder implantation technology
Description
The success of occluder implantation technology is defined as successful intraoperative implantation of occluder and immediate Echocardiography confirmed that the shape and position of the sealing device were appropriate, no new pericardial effusion or valve regurgitation was found, and the perioperative patients survived.
Time Frame
7 days after surgery
Title
Success rate of surgical implantation of occlusion
Description
Successful occluder implantation was defined as successful implantation of occluder and routine postoperative hospitalization that there were no serious adverse events related to surgery.
Time Frame
7 days after surgery
Title
Success rate of complete occlusion
Description
Complete occlusion was defined as the Transthoracic echocardiography (TTE) showing occlusion 180 days after surgery The position and shape of the apparatus were normal, and no horizontal atrial shunt was observed. The results of Contrast transthoracic echocardiography (cTTE) were reviewed there was no right-to-left shunt, that is, no microbubbles in the left heart cavity after Valsalva and resting state.
Time Frame
180 days after surgery
Title
Success rate of effective occlusion
Description
Success rate of effective occlusion was defined as: Transthoracic echocardiography (TTE) showed the position and shape of the occluder 360 days after the operation Normal condition, no horizontal atrial shunt; Reexamination by Contrast transthoracic echocardiography (cTTE) showed no or few results in other words, there were no microbubbles or less than 10 microbubbles in the left heart cavity after Valsalva and resting state.
Time Frame
360 days after surgery
Title
Recurrence or incidence of cryptogenic stroke during follow-up
Description
Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.
Time Frame
360 days, 2 years, 3 years, 4 years, 5 years after surgery
Title
All-cause mortality rate
Description
All-cause death is defined as death from any cause during the follow-up period.
Time Frame
360 days, 2 years, 3 years, 4 years, 5 years after surgery
Title
Incidence of new atrial fibrillation and atrial flutter during follow-up period
Description
atrial fibrillation and atrial flutter
Time Frame
360 days, 2 years, 3 years, 4 years, 5 years after surgery
Title
Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)
Description
Arterial embolism, Atrioventricular block III degree, heart abrasion, infective endocarditis, severe hemolytic anemia, etc.);
Time Frame
360 days, 2 years, 3 years, 4 years, 5 years after surgery
Title
Incidence of device defects.
Description
Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures.
Time Frame
360 days, 2 years, 3 years, 4 years, 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-60 years; Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent; Patent foramen ovale was confirmed by at least one of the following conditions exists: Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE); The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD); It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists: Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors; Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale; Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy; Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy. Exclusion Criteria: Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%); Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6 points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery blood supply area); Patients with intracardiac thrombosis or tumor, intracardiac vegetations; Acute myocardial infarction or unstable angina within 6 months; Left ventricular aneurysm formation or left ventricular wall movement disorder; Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery; Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure; Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm; Atrial fibrillation/atrial flutter (chronic or intermittent); Pregnant or planning to become pregnant during the trial; Patients with active endocarditis or other untreated infections or other hemorrhagic diseases; Pulmonary hypertension or patent foramen ovale was a special channel; Liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal value, serum creatinine (Cr) > 2 times the upper limit of normal value); Uncontrolled hypertension (> 180/100 mmHg); Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases; Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means; The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder; Thrombosis exists at the location or route of implantation; Malignant neoplasms or other diseases with a life expectancy of less than 2 years; Patients who could not be followed up during the trial; Participate in clinical trials of other drugs or medical devices within three months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Pan, Doctor
Phone
13811763898
Email
xiangbin428@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbo Yang, Bachelor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, Doctor
Organizational Affiliation
Fuwai Yunnan Cardiovascular Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liang
Phone
010-64008229
First Name & Middle Initial & Last Name & Degree
Wei Ma, Doctor
First Name & Middle Initial & Last Name & Degree
Tieci Yi, Doctor
Facility Name
Fuwai Hospital ,CAMS&PUMC
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanlu LI
Phone
010-68331753
First Name & Middle Initial & Last Name & Degree
Haibo Hu, Doctor
First Name & Middle Initial & Last Name & Degree
Jianhua Lv, Bachelor
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Tang
Phone
020-87608185
First Name & Middle Initial & Last Name & Degree
Zhongkai Wu, Doctor
First Name & Middle Initial & Last Name & Degree
Li Zhou, Doctor
Facility Name
Meizhou people'Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayou Yang
Phone
0753-2131905
First Name & Middle Initial & Last Name & Degree
Wei Zhong, Master
First Name & Middle Initial & Last Name & Degree
Zhixiong Zhong, Master
Facility Name
The Second XiangYa Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuankun Miao
Phone
0731-85292495
First Name & Middle Initial & Last Name & Degree
Zhenfei Fang, Doctor
First Name & Middle Initial & Last Name & Degree
Zhaowei Zhu, Doctor
Facility Name
The Third XiangYa Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxia Xiang
Phone
0731-88618931
First Name & Middle Initial & Last Name & Degree
Zhihui Zhang, Doctor
First Name & Middle Initial & Last Name & Degree
Fei Ye, Doctor
Facility Name
The First Hospital Of JiLin Universitv
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wang
Phone
15804301330
First Name & Middle Initial & Last Name & Degree
Yongsheng Gao, Master
First Name & Middle Initial & Last Name & Degree
Liming Yang, Bachelor
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongying Zhang
Phone
024-28897204
First Name & Middle Initial & Last Name & Degree
Qiguang Wang, Doctor
First Name & Middle Initial & Last Name & Degree
Ming Zhao, Maste
Facility Name
Qilu Hospitalof Shandong University
City
JInan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bailu Wang
Phone
18560080852
First Name & Middle Initial & Last Name & Degree
Xinhua Gu, Doctor
First Name & Middle Initial & Last Name & Degree
Fushun Lin, Doctor
Facility Name
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Yin
Phone
15806627462
First Name & Middle Initial & Last Name & Degree
Hongxin Li, Doctor
First Name & Middle Initial & Last Name & Degree
Shanliang Chen, Master
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da Zhu
Phone
(+86) 0871-65199777
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, Doctor
First Name & Middle Initial & Last Name & Degree
Hongbo Yang, Master
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Can Wang
Phone
0571-85893646
First Name & Middle Initial & Last Name & Degree
Lihong Wang, Doctor
First Name & Middle Initial & Last Name & Degree
Qiang Xu, Master
Facility Name
The First Affiliated Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingya Yang
Phone
0574-87085034
First Name & Middle Initial & Last Name & Degree
Huiming Chu, Master
First Name & Middle Initial & Last Name & Degree
Jing Liu, Master
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafang Chen
Phone
0577-55579590
First Name & Middle Initial & Last Name & Degree
Hao Zhou, Doctor
First Name & Middle Initial & Last Name & Degree
Xue Xia, Master

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

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