Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism (PMT-LDCDT-PE)
A Prospective Cohort Study Comparing Percutaneous Mechanical Thrombectomy Alone Versus Percutaneous Mechanical Thrombectomy Combined With Low-Dose Catheter-Directed Thrombolysis in the Treatment of Acute Intermediate-High Risk Pulmonary Embolism
Acute pulmonary embolism (PE) is the third most common cardiovascular cause of death. In patients with intermediate-high risk acute PE, percutaneous mechanical thrombectomy (PMT) using large-bore catheters achieves rapid hemodynamic improvement while avoiding the bleeding risk of systemic thrombolysis, and low-dose catheter-directed thrombolysis (CDT) can dissolve residual thrombus with a lower systemic bleeding risk. This prospective, multicenter, non-randomized cohort study aims to compare the safety and efficacy of PMT alone versus PMT combined with low-dose CDT (PMT+LDCDT) in patients with acute intermediate-high risk PE. Approximately 150 patients will be enrolled and allocated to either PMT alone or PMT+LDCDT based on operator assessment. The primary safety endpoint is the composite incidence of major adverse events (MAE) within 48 hours, and the primary efficacy endpoint is the change in the right ventricular/left ventricular (RV/LV) diameter ratio from baseline to 48 hours assessed by a CTPA core laboratory.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Acute PE is the third leading cause of cardiovascular death, and patients with intermediate-high risk PE-hemodynamically stable but with imaging-confirmed right ventricular dysfunction and elevated cardiac injury biomarkers-are at substantial risk of early deterioration. PMT with large-bore catheters enables immediate thrombus removal and hemodynamic recovery without systemic thrombolytic exposure, whereas CDT delivers low-dose thrombolytics locally to dissolve residual thrombus with a reduced systemic bleeding risk. Combining PMT with low-dose CDT (PMT+LDCDT) may improve thrombus clearance without a meaningful increase in bleeding. This prospective, multicenter cohort study will enroll approximately 150 patients with acute intermediate-high risk PE at centers with pulmonary vascular interventional capability. Patients will be allocated to PMT alone or PMT+LDCDT according to the operator's pre- and intra-procedural assessment. Participants will be followed at 24 h, 48 h, 7 days/discharge, 30 days, 90 days, 6 months and 12 months. The study will evaluate safety (48-hour MAE composite: all-cause death, intracranial hemorrhage, ISTH major bleeding and other major adverse events) and efficacy (change in RV/LV diameter ratio from baseline to 48 hours by CTPA core laboratory), as well as thrombus clearance, procedure time, length of stay, and the incidence of chronic thromboembolic pulmonary hypertension (CTEPH) at 6 and 12 months.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18-80 years.
- Acute pulmonary embolism confirmed by CTPA, with symptom onset to diagnosis ≤14 days.
- Imaging evidence of right ventricular dysfunction (CTPA RV/LV diameter ratio ≥1.0, or echocardiographic right ventricular dilation/hypokinesia) and elevated cardiac injury biomarkers (troponin I or T above the upper limit of normal).
- Presence of a contraindication to systemic thrombolysis, or failure of systemic thrombolysis, or clinical deterioration during anticoagulation.
- Thrombus visible in the main pulmonary artery and/or lobar arteries on CTPA.
- Provision of signed informed consent.
Exclusion Criteria:
- Cardiac arrest at enrollment; systolic blood pressure <80 mmHg for >15 minutes unresponsive to fluid resuscitation and vasopressors.
- Active bleeding; known coagulopathy (INR >2.0 or platelet count <50×10⁹/L); intracranial hemorrhage within 90 days, or intracranial tumor/vascular malformation; major surgery, major trauma, or stroke within 30 days.
- Known heparin allergy or a history of heparin-induced thrombocytopenia.
- Prior systemic thrombolytic therapy.
- Known chronic thromboembolic pulmonary hypertension (CTEPH); severe left ventricular dysfunction (LVEF <30%); severe valvular heart disease; end-stage renal disease (eGFR <30 mL/min/1.73 m²); pregnancy or lactation.
- Intracardiac or intrapulmonary mass on CTPA; severe stenosis or occlusion of the inferior vena cava or iliofemoral vein.
- CTPA image quality inadequate for independent core laboratory interpretation.
- Current participation in another clinical study that could interfere with endpoint assessment.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：PMT alone (percutaneous mechanical thrombectomy only)
PMT alone (percutaneous mechanical thrombectomy only) |
Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system) |
|
実験的：PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)
PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT) |
Low-dose catheter-directed thrombolysis: Alteplase (rt-PA), ≤20 mg (≤10 mg per lung), infused over ≤30 min via pulmonary artery catheter |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Composite incidence of major adverse events (MAE) within 48 hours after the procedure
時間枠：within 48 hours post-procedure
|
within 48 hours post-procedure
|
|
Change in the RV/LV diameter ratio from baseline to 48 hours (ΔRV/LV) measured by CTPA core laboratory
時間枠：baseline and 48 hours
|
baseline and 48 hours
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- WH6-PMT-LDCDT-2026-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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