Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden

NCT04248868 · View on ClinicalTrials.gov ↗

Study Summary

To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.

Conditions Studied

Interventions

  • DRUG r-tPA
  • DEVICE The Bashir™ Endovascular Catheter

Study Locations (19)

Pennsylvania

  • UPMC Hamot — Erie
  • Temple University Hospital — Philadelphia
  • UPMC Heart and Vascular Institute — Pittsburgh

Florida

  • Miami Cardiac & Vascular Institute — Miami
  • Advent Health Orlando — Orlando

Georgia

  • Emory — Atlanta
  • Piedmont Heart Institute — Atlanta

Michigan

  • Ascension St. John Hospital — Detroit
  • Beaumont Hospital, Royal Oak — Royal Oak

New York

  • St. Joseph's Hospital — Liverpool
  • NYU Langone — New York

California

  • UCLA — Los Angeles

Illinois

  • Loyola University Chicago — Maywood

Indiana

  • Ascension St. Vincent — Indianapolis

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2020-06-23
Est. Completion 2022-06-23
Phase Phase 3

Sponsor

Thrombolex

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04248868

The ClinicalTrials.gov registry entry for NCT04248868 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thrombolex, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions — of which r-tPA is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04248868 reports 19 study locations spanning 13 distinct geographic areas — top geographies include Pennsylvania, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04248868 about?

NCT04248868 is a clinical study titled "tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden". To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.

What is the current status of trial NCT04248868?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2020-06-23. Estimated completion is 2022-06-23.

What conditions does trial NCT04248868 study?

This clinical trial studies the following conditions: Pulmonary Embolism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04248868?

The interventions under investigation include: r-tPA (DRUG), The Bashir™ Endovascular Catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04248868?

This trial is sponsored by Thrombolex, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04248868 being conducted?

This trial has 19 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial