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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~within 7 days post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in RV/LV ratio
Secondary outcome measures
All-cause Mortality
Functional Outcome Assessment with the 6-minute walk test
Functional Outcome Assessment with the Borg Scale
+8 more

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.

Find a Location

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
35 Previous Clinical Trials
9,010 Total Patients Enrolled
2 Trials studying Pulmonary Embolism
719 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

Media Library

Anticoagulation (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05684796 — N/A
Pulmonary Embolism Research Study Groups: Anticoagulation (AC), Indigo
Pulmonary Embolism Clinical Trial 2023: Anticoagulation Highlights & Side Effects. Trial Name: NCT05684796 — N/A
Anticoagulation (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05684796 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study accept participants who are older than 20 years of age?

"Participants in this trial must be aged 18 or older and under the age of 80."

Answered by AI

What is the magnitude of participants involved in this experiment?

"Affirmative. Information located on the clinicaltrials.gov website indicates that this medical experiment is now in recruitment mode. It was first published on May 1st 2023 and most recently updated on May 29th 2023, with a requirement of 100 participants at one site."

Answered by AI

Are there any current recruiting opportunities for this clinical trial?

"Affirmative, the information on clinicaltrials.gov verifies that this trial is still recruiting patients. This experiment was posted to the website on May 1st 2023 and most recently updated at the end of the month. The medical study requires 100 individuals from one location."

Answered by AI

What criteria must potential participants meet in order to be eligible for this trial?

"In order to be considered for participation in this clinical trial, candidates must have been diagnosed with pulmonary embolism and fall between the ages of 18-80. One hundred individuals are expected to take part."

Answered by AI

Who else is applying?

What site did they apply to?
Ascension Saint Thomas Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Two Pulmonary Embolism Treatments
2023. "Comparison of Two Pulmonary Embolism Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05684796.
All > Pulmonary Embolism
~67 spots leftby Mar 2026
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