Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Conditions

• Pulmonary Embolism

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Anticoagulant Therapy — DRUG
  All subjects will receive anticoagulation for a minimum of 3 months.
• Catheter-Directed Therapy — DEVICE
  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

Study Details

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.

Key Dates

Start date

Jul 17, 2023

Status verified

May 2026

Primary completion

Mar 29, 2027

Completion

Aug 4, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Catheter-Directed Therapy (CDT) plus Anticoagulation
  Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
• Active Comparator: No Catheter-Directed Therapy (No-CDT)
  Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.

Primary Outcome Measure

Peak Oxygen Consumption (PVO2) [ Time Frame: Month 3 ]

Central Contacts

• Sunil Rao
  212-263-0456
  [email protected]
• Lei Lei
  212-263-4189
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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