급성 폐색전증을 가진 중국 인구의 에코 소닉 혈관 내 시스템에 대한 실제 연구 (ANTEATER)
중국 RWS (Anteater)의 Ekosonic endovascular 시스템
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
연구 개요
상세 설명
This is a multi-center, single arm, prospective, observational, real-world study.To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
Up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Guangqi Chang, Doctor
- 전화번호: 020-87755766
- 이메일: changgq@mail.sysu.edu.cn
연구 연락처 백업
- 이름: Cheng Hong, Doctor
- 전화번호: 020-81568636
- 이메일: gyfyyhc@126.com
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510000
- 모병
- The first Affiliated Hospital, Sun Yat-sen University
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연락하다:
- Cheng Hong, Doctor
- 전화번호: 020-81568636
- 이메일: gyfyyhc@126.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
This study will enroll patients who received EkoSonicTM Endovascular System treatment with r-tPA for acute pulmonary thromboembolism, and who could provide sufficient echocardiographic quality to assess the collection of primary endpoint, and prospectively collect the clinical data related to the protocol in the actual clinical diagnosis and treatment
설명
Inclusion Criteria:
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Exclusion Criteria:
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Single group observational study
To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care. |
EkoSonicTM Endovascular System and its upgraded versions if applicable The EkoSonicTM Endovascular System is a non-implanted system comprising a sterile, single-use EkoSonic Endovascular Device (Infusion Catheter and Ultrasonic Core) and reusable EKOSTM Control System 4.0(Control Unit, Connector Interface Cable and power cord). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
RV vs LV end-diastolic diameter ratio
기간: after the completion of EKOS treatment 48 hours compared with the baseline
|
The change in the right ventricular end-diastolic diameter to left ventricle end-diastolic diameter ratio at 48hours after the completion of EKOS treatment compared with the baseline. |
after the completion of EKOS treatment 48 hours compared with the baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
RV vs LV end-diastolic diameter ratio
기간: after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
|
The change in the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio at 24h, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline. |
after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
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PE events after the completion of EKOS treatment
기간: After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
|
Recurrent symptomatic PE events after the completion of EKOS treatment. |
After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
|
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Serious adverse events related to EKOS or procedure
기간: After enrollment to end of study，through study completion, an average of 1 year
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All of SAE related to EKOS or procedure |
After enrollment to end of study，through study completion, an average of 1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Guangqi Chang, Doctor, First Affiliated Hospital, Sun Yat-Sen University
- 수석 연구원: Cheng Hong, Doctor, The First Affiliated Hospital of Guangzhou Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- S6364
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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