Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Akura Medical
Study ID
NCT06672510
Status
Recruiting
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Conditions

  • Pulmonary Embolism Acute

Eligibility Criteria

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

Interventions

  • ATC — DEVICE
    The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P

Study Details

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Patients with Acute Pulmonary Embolism
    Patients undergoing mechanical thrombectomy for acute pulmonary embolism.

Primary Outcome Measure

Effectiveness [ Time Frame: 48 hours ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Mane Arabyan
[email protected]
Saibal Kar (PRINCIPAL_INVESTIGATOR)
Advanced Heart & Vein (ClinRe-001-001)ThorntonColorado80023
Salman Gondal
[email protected]
Ehrin Armstrong (PRINCIPAL_INVESTIGATOR)
Hartford HealthcareHartfordConnecticut06102
Vicky Macleod
[email protected]
Joseph Ingrassia (PRINCIPAL_INVESTIGATOR)
Manatee Hospital / Nova Clinical Research CenterBradentonFlorida32808-
Jacksonville Memorial (HCA)JacksonvilleFlorida32216-
Tallahasse Memorial HospitalTallahasseeFlorida32308
Vuppalapu Vidhath
[email protected]
Vuppalapu Vidhath
Andres Vargas Estrada (PRINCIPAL_INVESTIGATOR)
Centracare Heart & Vascular CenterSaint CloudMinnesota56301
Jennifer Humbert
[email protected]
Brian Stegman, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Suzanne Edwards
[email protected]
Ari Mintz (PRINCIPAL_INVESTIGATOR)
Cumc/NyphNew YorkNew York10032
Suzanne Edwards
[email protected]
Ari Mintz (PRINCIPAL_INVESTIGATOR)
ProMedica Toledo HospitalToledoOhio43606
cassandra kupniewski
[email protected]
Ahmad Younes (PRINCIPAL_INVESTIGATOR)
Tristar Centennial Medical CenterNashvilleTennessee37203
Anna Morse, BSN RN
[email protected]
Ann Gage (PRINCIPAL_INVESTIGATOR)
Methodist San Antonio (HCA)San AntonioTexas78229
Susana Mondaca
[email protected]
Charles Burch (PRINCIPAL_INVESTIGATOR)

Find similar trials in Thousand Oaks, CA

By research site
Los Robles Regional Medical Center· Thousand Oaks, CAAdvanced Heart & Vein (ClinRe-001-001)· Thornton, COHartford Healthcare· Hartford, CTManatee Hospital / Nova Clinical Research Center· Bradenton, FLJacksonville Memorial (HCA)· Jacksonville, FLTallahasse Memorial Hospital· Tallahassee, FL

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