Pulmonary EmbolismEXTRACT-PENCT03218566
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
A study testing Indigo Aspiration System in people with Pulmonary Embolism, run by Penumbra Inc. at 22 sites in United States.
Trial summary
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Indigo Aspiration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 22 sitesUnited States
- Study dates
- 22 Nov 2017to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
- Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9
- Patient is 18 years of age or older
Who cannot join
- tPA use within 14 days prior to baseline CTA
- Systolic BP < 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
- Pulmonary hypertension with peak PA > 70 mmHg by right heart catheterization
- History of severe or chronic pulmonary hypertension
- Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90%
- Hematocrit < 28%
Show all 22Show fewer
- Platelets < 100,000µL
- Serum creatinine > 1.8 mg/dL
- INR > 3
- aPTT (or PTT) > 50 seconds on no anticoagulation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of anticoagulants
- Major trauma < 14 days
- Presence of intracardiac lead
- Cardiovascular or pulmonary surgery within last 7 days
- Cancer requiring active chemotherapy
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 90 days
- Female who is pregnant
- Intracardiac Thrombus
- Patients on ECMO
- Current participation in another investigational study
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Grady Health System
Atlanta, Georgia, 30303
Our Lady of the Lake Hospital Inc.
Baton Rouge, Louisiana, 70808
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25309
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Detroit Medical Center
Detroit, Michigan, 48201
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA Medical Center
Los Angeles, California, 90095
Baptist Hospital of Miami
Miami, Florida, 33176
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
New York University (NYU) Langone Medical Center
New York, New York, 10016
Mount Sinai
New York, New York, 10029
Christiana Care
Newark, Delaware, 19713
Sentara Vascular Specialists
Norfolk, Virginia, 23507
St. Joseph Health Hospital
Orange, California, 92868
University of Pennsylvania Medical Center (UPMC)
Pittsburgh, Pennsylvania, 16148
North Carolina Heart and Vascular Research (NCHVR)
Raleigh, North Carolina, 27607
Sanford Health
Sioux Falls, South Dakota, 57117
Mercy Hospital South
St Louis, Missouri, 63128
AdventHealth Tampa
Tampa, Florida, 33613
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
About this study
Official title: A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
- Conditions
- Pulmonary Embolism
- Being tested
- Indigo Aspiration System
- Keywords
- pulmonary embolism, clot
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigo Aspiration SystemDevice
use of mechanical thrombectomy to treat pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism Receives: Device: Indigo Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricle/Left Ventricle (RV:LV) Ratio
Change in RV/LV ratio per CTA
Measured: from baseline to 48 hours
Major Adverse Event Rate
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Measured: within 48 hours
Secondary outcomes (8)
Device-related Death Rate
Measured: within 48 hours
Major Bleeding Rate
Measured: within 48 hours
Clinical Deterioration Rate
Measured: within 48 hours
Pulmonary Vascular Injury Rate
Measured: within 48 hours
Cardiac Injury Rate
Measured: within 48 hours
Any-cause Mortality
Measured: within 30 days
Device-related SAE Rate
Measured: within 30 days
Symptomatic PE Recurrence Rate
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start22 Nov 2017
- Primary completion10 Mar 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhilesh Sista, MD, Principal investigator, NYU-Langone School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218566
- Sponsor's protocol ID
- 11373
- Acronym
- EXTRACT-PE
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2017
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jorge JV, Barreiros CA, Silva D, Cale R, Ribeiro JM. Extracorporeal mechanical support and aspiration thrombectomy in treatment of massive pulmonary embolism: a case report. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):524-528. doi: 10.5935/0103-507X.20220342-pt. Epub 2023 Mar 3.
PubMed 36888834Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.
PubMed 33454291
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03218566
- Acronym / sponsor ID
- EXTRACT-PE / 11373
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, clot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Indigo Aspiration SystemSingle Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
- Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9
- Patient is 18 years of age or older
Key exclusion criteria (22 listed)
- tPA use within 14 days prior to baseline CTA
- Systolic BP < 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
- Pulmonary hypertension with peak PA > 70 mmHg by right heart catheterization
- History of severe or chronic pulmonary hypertension
- Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigo Aspiration Systemuse of mechanical thrombectomy to treat pulmonary embolism | Device | Single Arm |
Primary outcome
Right Ventricle/Left Ventricle (RV:LV) Ratio
Time frame: from baseline to 48 hours
Change in RV/LV ratio per CTA
Major Adverse Event Rate
Time frame: within 48 hours
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
8 secondary outcomes
Device-related Death Rate
Time frame: within 48 hours
Major Bleeding Rate
Time frame: within 48 hours
Clinical Deterioration Rate
Time frame: within 48 hours
Pulmonary Vascular Injury Rate
Time frame: within 48 hours
Cardiac Injury Rate
Time frame: within 48 hours
Any-cause Mortality
Time frame: within 30 days
Device-related SAE Rate
Time frame: within 30 days
Symptomatic PE Recurrence Rate
Time frame: within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36888834Jorge JV, Barreiros CA, Silva D, Cale R, Ribeiro JM. Extracorporeal mechanical support and aspiration thrombectomy in treatment of massive pulmonary embolism: a case report. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):524-528. doi: 10.5935/0103-507X.20220342-pt. Epub 2023 Mar 3.
- Derived from this study: PubMed 33454291Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akhilesh Sista, MD principal investigator
NYU-Langone School of Medicine
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigo Aspiration System in people with Pulmonary Embolism, run by Penumbra Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Ventricle/Left Ventricle (RV:LV) Ratio (time frame: from baseline to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.