Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Part of paid clinical trials in Long Beach, California.

Sponsor
Penumbra Inc.
Study ID
NCT04798261
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Embolism

Eligibility Criteria

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

Interventions

  • Indigo Aspiration System — DEVICE
    Indigo Aspiration System

Study Details

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

Key Dates

Start date
Jun 25, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Feb 29, 2028

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Patients with acute pulmonary embolism

Primary Outcome Measure

Safety: Composite of major adverse events [ Time Frame: 48 hours ]

Central Contacts

Locations (57)

FacilityCityStateZIPSite coordinators
Long Beach Medical CenterLong BeachCalifornia90806-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
UCLA Medical CenterLos AngelesCalifornia90095-
UC Irvine Medical CenterOrangeCalifornia92868-
Sharp Memorial HospitalSan DiegoCalifornia92123-
UCSD JacobsSan DiegoCalifornia92037-
Christiana Care HospitalNewarkDelaware19718-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Manatee Memorial HospitalBradentonFlorida34205-
Blake Medical Center/Nova Clinical ResearchBrandentonFlorida34209-
Delray Medical Center, Inc.Delray BeachFlorida33484-
University of Florida Shands HospitalGainesvilleFlorida32608-
Radiology and Imaging SpecialistsLakelandFlorida33805-
Baptist Health Miami Cardiac and Vascular InstituteMiamiFlorida33176-
Jackson Memorial HospitalMiamiFlorida33136-
AdventHealth OrlandoOrlandoFlorida32803-
HCA Florida Northside HospitalPetersburgFlorida33709-
St. Joseph Hospital - BayCareTampaFlorida33614-
Tampa General HospitalTampaFlorida33606-
University Hospital AugustaAugustaGeorgia30901-
Memorial Hospital BellevilleBellevilleIllinois62226-
Loyola University Medical CenterMaywoodIllinois600153-
KUMCKansas CityKansas66160-
LSU Health Sciences CenterShreveportLouisiana71103-
Massachusetts General HospitalBostonMassachusetts02114-
Charlton Memorial HospitalFall RiverMassachusetts02720-
Ascension St. John HospitalDetroitMichigan48236-
University of MinnesotaMinneapolisMinnesota55455-
University of Mississippi Medical CenterJacksonMississippi39216-
Mercy Hospital SouthSt LouisMissouri63128-
Cooper Health SystemCamdenNew Jersey08103-
Lovelace Health SystemAlbuquerqueNew Mexico87102-
Bellevue Hospital CenterNew YorkNew York10016-
Columbia University Medical Center/NYPHNew YorkNew York10032-
Mount Sinai HospitalNew YorkNew York10029-
St. Francis Hospital and Heart CenterRoslynNew York11576-
Staten Island University HospitalStaten IslandNew York10305-
SUNY Upstate Medical UniversitySyracuseNew York13210-
NC Heart and Vascular ResearchRaleighNorth Carolina27607-
Christ HospitalCincinnatiOhio45219-
TriHealth Good Samaritan HospitalCincinnatiOhio45220-
Mount Carmel EastColumbusOhio43213-
Kettering Medical CenterKetteringOhio45429-
ProMedica Toledo HospitalToledoOhio43606-
INTEGRIS Baptist Medical CenterOklahoma CityOklahoma73112-
Hillcrest Medical CenterTulsaOklahoma74104-
UPMC HarrisburgHarrisburgPennsylvania17101-
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Temple University HospitalPhiladelphiaPennsylvania19140-
Miriam HospitalProvidenceRhode Island02903-
Jackson-Madison County General HospitalJacksonTennessee38301-
Turkey Creek Medical CenterKnoxvilleTennessee37934-
Methodist Hospital MetropolitanSan AntonioTexas78112-
Houston Methodist The Woodlands HospitalThe WoodlandsTexas77385-
Christus Mother Frances HospitalTylerTexas75701-
Sentara Norfolk GeneralNorfolkVirginia23507-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Long Beach, CA

By research site
Long Beach Medical Center· Long Beach, CACedars-Sinai Medical Center· Los Angeles, CAUCLA Medical Center· Los Angeles, CAUC Irvine Medical Center· Orange, CASharp Memorial Hospital· San Diego, CAUCSD Jacobs· San Diego, CA

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