Evidence map›Paper›PMID 42056311›Full record

ArticleCardiovascular and interventional radiology2026

Multi-center Randomized Controlled Trial of Catheter-Directed Mechanical Thrombectomy Versus Systemic Thrombolysis in Patients with Acute Intermediate-to-High-Risk Pulmonary Embolism: Study Protocol.

Cheng Wang, Peiliang Fang, Daibing Zhou, Bin Xu, Xixi Dai, Zhenzhou Zhang, Mengshi Xie, Zhiyong Duan, Liang Zhang, Yongjun Li and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Publisher
In one paragraph

Article in Cardiovascular and interventional radiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07032025 (A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07032025 early_phase1not yet recruitingnot on this map

A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.

TypeinterventionalSponsorRenJi HospitalRan2025 to 2027Enrolled200ConditionsAcute Pulmonary EmbolismArmsInnovative Device Group, Standard Pharmacological Therapy Group
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Cheng Wang *Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Peiliang Fang *Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Daibing Zhou *Department of Pulmonary and Critical Care Medicine, Huashan Hospital Fudan University, Shanghai, China.
Bin Xu *Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xixi DaiDepartment of Cardiology, Zhongshan Hospital Wusong Branch, Fudan University, Shanghai, China.
Zhenzhou ZhangDepartment of Cardiology, Zhongshan Hospital Wusong Branch, Fudan University, Shanghai, China.
Mengshi XieDepartment of Cardiology, Zhongshan Hospital Wusong Branch, Fudan University, Shanghai, China.
Zhiyong DuanDepartment of Cardiology, Zhongshan Hospital Wusong Branch, Fudan University, Shanghai, China.
Liang ZhangDepartment of Cardiology, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Yongjun LiDepartment of Cardiology, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Yanhua ZhuDepartment of Cardiology, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Yi JiangEmergency Department, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Liangyi QieDepartment of Geriatric Medicine and Laboratory of Gerontology and Anti-Aging Research, Qilu Hospital of Shandong University, Shandong, China.
Hongyu ShiDepartment of Cardiology, Zhongshan Hospital Wusong Branch, Fudan University, Shanghai, China.
Jiaxuan FengVascular Surgery Department, Ruijin Hospital, School of medicine, Shanghai Jiaotong University, Shanghai, China.
Wenguang ZhangDepartment of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Xian JinDepartment of Cardiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China. jinxianian@126.com.

Funding

Henan Provincial Science and Technology Research Project 252102310060Shanghai Baoshan Science and Technology Commission BSWSYX-20242Shanghai Shen Kang Hospital Development Center SHDC2023CRD026The Jiading District Key Medical Specialty (Category A) Construction Project ZK2024A03
6 · The paper itself

Abstract

purposeThis study aims to compare the efficacy and safety of catheter-directed mechanical thrombectomy using the Tendvia system versus systemic thrombolysis in patients with intermediate-to-high-risk acute pulmonary embolism. MATERIALS AND

methodsThis is a 1:1 block-randomized, controlled, open-label parallel-group, multi-center, superiority trial. Eligible patients aged 18-75 years, diagnosed with intermediate-to-high-risk acute pulmonary embolism and hemodynamic deterioration, will be included. The main exclusion criteria are unsuitable target vessel criteria; sustained systolic hypotension; severe pulmonary hypertension; hematocrit < 28%; chronic pulmonary hypertension; left bundle branch block; chronic left heart failure; renal dysfunction; coagulopathy; recent cardiothoracic surgery; intracardiac thrombus. The intervention group will undergo catheter-directed thrombectomy using the Tendvia system under fluoroscopic guidance within 4 h of computed tomography pulmonary angiography. The control group will receive standard alteplase infusion. The primary efficacy endpoint is absolute reduction in the right ventricular/left ventricular diameter ratio from baseline to 48 h post-intervention, measured by blinded core-lab computed tomography pulmonary angiography analysis. The primary safety endpoint is the rate of composite major adverse events within 48 h. Secondary endpoints include the proportion of patients achieving a ≥ 50% reduction from baseline in NT-proBNP level at 48 h post-intervention, dyspnea scores, change in pulmonary arterial pressure, 48-h post-procedure clinical deterioration, symptomatic recurrence within 30 days, major access site complications, device-related serious adverse events, length of post-procedure hospital and intensive care unit stay, and change in cardiac biomarkers. EXPECTED GAIN OF KNOWLEDGE: This trial will provide evidence regarding the use of catheter-directed thrombectomy in intermediate-to-high-risk pulmonary embolism.

trial registrationThis study was registered in Clinicaltrials.gov on 2025-06-22 (Registration number NCT07032025).

Indexed as

Fibrinolytic AgentsPulmonary EmbolismThrombectomyThrombolytic TherapyAcute DiseaseAdolescentAdultAgedComputed Tomography AngiographyEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicFibrinolytic AgentsTissue Plasminogen ActivatorAnticoagulantCatheter-directed thrombectomyIntermediate-to-high-risk pulmonary embolismMechanical thrombectomyPulmonary embolismSubmassive pulmonary embolismSystemic thrombolysis

Identifiers

PMID42056311

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.