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Device

BEC Catheter for Pulmonary Embolism

N/A

Waitlist Available

Led By Parth Rali, MD

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to ≤ 75 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once r-tpa pulse sprays are given continue therapeutic anticoagulation with full does heparin or lmwh with sheaths sutured in place

Awards & highlights

Study Summary

This trial tests a new catheter to safely treat blood clots in the lungs with a drug and special spray.

Who is the study for?

This trial is for adults aged 18-75 with a recent (≤14 days) pulmonary embolism, confirmed by CT scan, who can consent to treatment. They must have certain heart imaging findings and be able to follow study procedures. Exclusions include severe bleeding risks, pregnancy, major surgery within the past two weeks, and other specific health conditions.Check my eligibility

What is being tested?

The RESCUE II Study tests the Bashir™ Endovascular Catheter's safety and effectiveness in delivering targeted medication directly to blood clots in the lungs using a special pulse spray technique for patients with acute submassive pulmonary embolism.See study design

What are the potential side effects?

Potential side effects may include bleeding complications due to clot-dissolving medications delivered by the catheter. There might also be risks associated with catheter insertion such as infection or damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation

Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment

Secondary outcome measures

Adverse events

All-cause mortality

Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients who present with PEExperimental Treatment1 Intervention

The Bashir™ Endovascular Catheter (BEC) is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. Two sizes of BECs will be used in this study

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Temple UniversityLead Sponsor

297 Previous Clinical Trials

82,953 Total Patients Enrolled

Parth Rali, MDPrincipal InvestigatorTemple University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific trial facilitating the participation of individuals above 80 years old?

"This clinical trial's minimum age of entry is 18, with the upper eligibility limit set at 75."

Answered by AI

Are there vacancies in this clinical trial that can be filled?

"This medical trial, initially published on November 1st 2023 and last amended the same day, is not presently accepting patients. Nonetheless, 87 other studies are currently searching for participants to join their trials."

Answered by AI

What are the key results this clinical trial seeks to accomplish?

"This clinical study seeks to evaluate the safety and efficacy of rtPA through a 30-day follow up period. The primary outcome measure is major bleeding (as defined by International Society of Thrombosis and Hemostasis standards) within 72 hours of treatment initiation. Secondary endpoints include all cause mortality at hospital discharge, serious adverse events, and general adverse events over the course of 30 days following infusion."

Answered by AI

Which individuals have the necessary qualifications for participating in this medical study?

"The protocol of this clinical trial stipulates that participants must have acute pulmonary embolism and be within the age range 18-75. A maximum of 20 applicants will be accepted into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The RESCUE II Study. The Bashir™ Endovascular Catheter (BEC),

2023. "The RESCUE II Study. The Bashir™ Endovascular Catheter (BEC),". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120179.

All > Pulmonary Embolism