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.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
Research Objective:
To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care.
Research Content:
Patients meeting all the following criteria will be enrolled:
Aged 18-75 years (male or female)
Clinically diagnosed with acute PE
Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
Provision of voluntary written informed consent.
Study Design:
After confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups:
Innovative Device Group: Minimally invasive thrombectomy
Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation
Study Endpoints:
Primary Efficacy Endpoint:
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as:
Procedure-related death
Major bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding)
Treatment-related clinical deterioration, including:
Unplanned mechanical ventilation
Arterial hypotension (systolic blood pressure <90 mmHg for >1 hour or requiring vasopressors) or shock
Cardiopulmonary resuscitation
Sustained deterioration in oxygenation
Emergency surgical embolectomy.
Key Terminology Notes:
RV/LV: Right Ventricular/Left Ventricular diameter ratio (standard medical abbreviation retained).
VARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria).
PTFE: Polytetrafluoroethylene (material name preserved).
MAE: Major Adverse Events (acronym defined at first use).
Clinical deterioration: Explicitly specified with objective clinical indicators.
This translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.
详细描述
- Research Objective To prospectively evaluate the comparative efficacy and safety of a novel ultra-thin polytetrafluoroethylene (PTFE) minimally invasive thrombectomy system versus guideline-directed pharmacological thrombolysis in patients with acute intermediate-high-risk pulmonary embolism (PE), both administered as adjuncts to standard anticoagulation therapy.
- Study Population
Inclusion Criteria:
Adults aged 18-75 years (all genders)
Acute PE confirmed by computed tomographic pulmonary angiography (CTPA) within 14 days of symptom onset
Right ventricular dysfunction defined as RV/LV diameter ratio ≥0.9 on baseline CTPA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years (male or female)
- •Clinically diagnosed with acute PE
- •Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
- •Provision of voluntary written informed consent.
排除标准
- •Target vessel diameter <6 mm
- •Calcification, plaque, or stenosis in target lesion
- •Sustained systolic blood pressure <90 mmHg for >15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg
- •Peak pulmonary artery pressure >70 mmHg
- •Hematocrit <28%
- •History of chronic pulmonary hypertension
- •Pre-existing left bundle branch block
- •Chronic left heart failure with left ventricular ejection fraction (LVEF) ≤30%
- •Renal dysfunction (serum creatinine >1.8 mg/dL or >159 μmol/L)
- •Known coagulopathy or bleeding diathesis:
- •Platelet count <50×10⁹/L, or International Normalized Ratio (INR) >3
- •Contraindications to antiplatelet/anticoagulant therapy
- •Cardiothoracic or pulmonary surgery within 7 days prior
- •Intracardiac thrombus
- •Patients on extracorporeal membrane oxygenation (ECMO)
- •Known hypersensitivity to iodinated contrast media
- •Significant comorbidities complicating treatment/evaluation:
- •Active malignancy Acute infectious disease/sepsis Systemic conditions precluding procedure tolerance Life expectancy <1 year
- •Pregnant or lactating women
- •Concurrent participation in other drug/device trials
- •Other investigator-determined unsuitability
研究组 & 干预措施
Innovative Device Group: Minimally invasive thrombectomy
干预措施: Innovative Device Group (Procedure)
Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation
干预措施: Standard Pharmacological Therapy Group (Drug)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 48 hours post-treatment.
Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.
Primary Safety Endpoint:
时间窗: 48 hours post-treatment
Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment
次要结局
未报告次要终点
研究者
Jun Pu
Professor, Chief Physician
RenJi Hospital