The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Thrombolex, Inc.
Study ID
NCT06433011
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Embolism

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Bashir™ Endovascular Catheter — DEVICE
    The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
  • r-tPA — DRUG
    Pulse spray and infusion

Study Details

To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).

Key Dates

First listed
May 29, 2024
Start date
Oct 17, 2024
Status verified
Jul 2026
Primary completion
Apr 25, 2028
Completion
Apr 25, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BEC Treatment
    The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

Primary Outcome Measure

Efficacy: Death from any cause or hemodynamic decompensation (or collapse) [ Time Frame: Procedure through 7-day follow-up ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258
Chintan Patel
480-323-1046
Carondelet St. Joseph's HospitalTusconArizona85711
Sundeep Shenoy
520-873-1591
Radiology and Imaging SpecialistsLakelandFlorida33801
Kurt Gordon
"863-688-2334
Emory UniversityAtlantaGeorgia30308
Pratik Sandesara
404-686-7468
Rush University Medical CenterChicagoIllinois60612
Bulent Arslan
434-242-8364
Profound ResearchHobartIndiana46342
Anas Safadi
Community HealthIndianapolisIndiana46256
Michael Robertson
317-621-7724
Beth Israel Deaconess Medical CenterBostonMassachusetts02481
Jeffrey Weinstein
617-754-2523
Boston Medical CenterBostonMassachusetts02135
Tariq Bhat
617-779-6731
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805
Michael Levy
781-744-8460
North Mississippi Medical CenterTupeloMississippi38801
Barry Bertolet
662-213-0405
Dartmouth HitchcockLebanonNew Hampshire03756
Michael Young
615-927-9043
Cooper HealthCamdenNew Jersey08103
Elias Iliadis
856-757-7832
St. Joseph'sLiverpoolNew York13088
Ayman Iskander
315-234-4412
Northwell HealthManhassetNew York11030
Vincent Gallo
718-226-6422
Mount SinaiNew YorkNew York10029
Jenanan Vairavamurthy
212-659-9151
TriHealthCincinnatiOhio45242
Adam Reichard
513-865-9898
Miami Valley/Wright State University/Premier HealthDaytonOhio45435
Ryan Brandt
937-208-3689
Jobst Vascular Institute - ProMedica HospitalToledoOhio43606
Ahmad Younes
419-291-2111
Temple UniversityPhiladelphiaPennsylvania19140
Parth Rali
215-707-1359
Vanderbilt University Medical CenterNashvilleTennessee37232
Alexander Sullivan
615-343-8647
SentaraNorfolkVirginia23507
David Dexter
757-395-1600
Charleston Area Medical CenterCharlestonWest Virginia25304
Mohammad Eslami
304-388-5432

Find similar trials in Scottsdale, AZ

By research site
Honor Health· Scottsdale, AZCarondelet St. Joseph's Hospital· Tuscon, AZRadiology and Imaging Specialists· Lakeland, FLEmory University· Atlanta, GARush University Medical Center· Chicago, ILProfound Research· Hobart, IN

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