Trials / Recruiting
RecruitingNCT05591118
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anticoagulant Therapy | All subjects will receive anticoagulation for a minimum of 3 months. |
| DEVICE | Catheter-Directed Therapy | The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE |
Timeline
- Start date
- 2023-07-17
- Primary completion
- 2027-03-29
- Completion
- 2027-06-26
- First posted
- 2022-10-24
- Last updated
- 2025-06-19
Locations
40 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05591118. Inclusion in this directory is not an endorsement.