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NCT03927508

First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

Completed Phase 1 Results posted Last updated 30 March 2023
What this trial tests

Phase 1 trial testing r-tPA in Pulmonary Embolism in 9 participants. Completed in 23 January 2020.

Timeline
14 March 2019
Primary endpoint
19 December 2019
23 January 2020

Quick facts

Lead sponsorThrombolex, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date14 March 2019
Primary completion19 December 2019
Estimated completion23 January 2020
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Thrombolex, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety: Number of Participants With Major Bleeding Events Primary · Within 72 hours of initiation of r-tPA administration.

Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.

GroupValue95% CI
BEC Treatment1

Adverse events — posted to ClinicalTrials.gov

Time frame: From treatment through 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BEC Treatment
Serious: 1/9 (11%)
Deaths: 0/9

Serious adverse events (1 terms)

ReactionSystemBEC Treatment
HematomaVascular disorders
Other adverse events (8 terms — click to expand)

ReactionSystemBEC Treatment
PainGeneral disorders
TendernessGeneral disorders
Injection site painGeneral disorders
occult bloodInvestigations
tooth injuryInjury, poisoning and procedural complications
HypoaesthiaNervous system disorders
Bronchial wall thickeningRespiratory, thoracic and mediastinal disorders
Odema peripheralGeneral disorders

Most-reported serious reactions: Hematoma.

Data from ClinicalTrials.gov NCT03927508 adverse events section.

Sponsor's own description

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.
    Sista AK, Bhatheja R, Rali P, Natarajan K, et al · · 2021 · cited 16× · PMID 33356383 · DOI 10.1161/circinterventions.120.009611
  2. Contemporary Catheter-Based Treatment Options for Management of Acute Pulmonary Embolism.
    Singh M, Shafi I, Rali P, Panaro J, et al · · 2021 · cited 13× · PMID 33994774 · DOI 10.1007/s11936-021-00920-7
  3. Management of Acute Pulmonary Embolism.
    Tice C, Seigerman M, Fiorilli P, Pugliese SC, et al · · 2020 · cited 12× · PMID 33042325 · DOI 10.1007/s12170-020-00659-z
  4. Current Insights for Catheter-Directed Therapies in Acute Pulmonary Embolism: Systematic Review and Our Single-Center Experience.
    Kaymaz C, Tokgöz HC, Kültürsay B, Hakgör A, et al · · 2023 · cited 9× · PMID 37599636 · DOI 10.14744/anatoljcardiol.2023.3639
  5. Research progress in interventional therapy for acute intermediate-high-risk and high-risk pulmonary embolism.
    Wang L, Yu C, Hu K, Guo Y, et al · · 2024 · cited 3× · PMID 39678886 · DOI 10.21037/jtd-24-1049

Verify or expand the search:

Other trials of r-tPA

Trials testing the same drug.

Other recruiting trials for Pulmonary Embolism

Currently open trials in the same condition.

Other Thrombolex, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03927508.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing