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Anticoagulant
Anticoagulation vs Thrombectomy for Pulmonary Embolism
N/A
Recruiting
Led By Rachel Rosovsky, MD
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days post-randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses the safety and effectiveness of treating acute pulmonary embolism with anticoagulants alone or with anticoagulants plus a mechanical device.
Who is the study for?
Adults aged 18-80 with recent acute pulmonary embolism confirmed by imaging, showing specific heart strain and elevated heart markers. Candidates must have suitable veins for the procedure and give informed consent. Excluded are those with active cancer, severe blood pressure issues, certain allergies or bleeding disorders, recent major surgery, pregnancy, or other investigational trial participation.
What is being tested?
The study compares two treatments for serious lung clots: standard blood thinners alone versus blood thinners plus a device that physically removes clots (Indigo Aspiration System). The goal is to see which method is safer and more effective.
What are the potential side effects?
Possible side effects include bleeding complications from anticoagulation therapy and risks associated with mechanical thrombectomy like vessel injury. Allergic reactions to contrast dye used in imaging may also occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in RV/LV ratio
Secondary study objectives
All-cause Mortality
Functional Outcome Assessment with the 6-minute walk test
Functional Outcome Assessment with the Borg Scale
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Anticoagulation (AC)Active Control1 Intervention
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
Group II: IndigoActive Control1 Intervention
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
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Who is running the clinical trial?
Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
10,351 Total Patients Enrolled
2 Trials studying Pulmonary Embolism
1,619 Patients Enrolled for Pulmonary Embolism
Rachel Rosovsky, MDPrincipal InvestigatorMassachusetts General Hospital
Robert Lookstein, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
3 Previous Clinical Trials
1,282 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My veins are suitable for a specific lung artery procedure.I have severe heart or blood pressure problems needing intense support.I have a confirmed pulmonary embolism shown by a CT scan.I have had signs of a pulmonary embolism for 14 days or less.I have been or will be actively treated for cancer, excluding non-melanoma skin cancer, in the last 6 months.I haven't taken blood clot treatment drugs in the last 30 days.I do not have active bleeding or conditions that prevent me from taking blood thinners.I have not had heart or lung surgery in the past week.I have been diagnosed with CTEPH or CTED based on my medical history or tests.I am between 18 and 80 years old.My PE is classified as intermediate high-risk with specific heart and blood markers.I do not have a severe infection requiring treatment now.
Research Study Groups:
This trial has the following groups:- Group 1: Anticoagulation (AC)
- Group 2: Indigo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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