Trial Outcomes & Findings for Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I (NCT NCT06571760)

Last Updated: 2026-05-19

Results Overview

The RV/LV diameter ratio is defined as the ratio of the maximal right ventricle (RV) to left ventricle (LV) diameters measured on computed tomography (CT) pulmonary angiography images. Measurements are performed by an independent core laboratory using standardized axial CT images, with ventricular diameters measured at the widest point of each ventricle. Change in RV/LV ratio is calculated for each participant as the difference between the value obtained at baseline (pre-procedure) and the value obtained at 48 hours post-procedure or at hospital discharge, whichever occurs first. A reduction in RV/LV ratio indicates improvement in right ventricular dilatation.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

From baseline to 48 hours or discharge

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Vertex Pulmonary Embolectomy System Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vertex Pulmonary Embolectomy System n=10 Participants Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Age, Continuous	67.2 years STANDARD_DEVIATION 6.5 • n=30 Participants
Sex: Female, Male Female	6 Participants n=30 Participants
Sex: Female, Male Male	4 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	10 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment Austria	5 participants n=30 Participants
Region of Enrollment Poland	5 participants n=30 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Grade 0	0 Participants n=30 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Grade 1	0 Participants n=30 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Grade 2	1 Participants n=30 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Grade 3	4 Participants n=30 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Grade 4	5 Participants n=30 Participants
Injury severity score (ISS) ISS <15 (study eligibility criterion)	10 Participants n=30 Participants
Injury severity score (ISS) ISS ≥15	0 Participants n=30 Participants
Serum Creatinine Serum baseline creatinine ≤ 1.8 mg/dL (eligibility criterion)	10 Participants n=30 Participants
Serum Creatinine Serum baseline creatinine > 1.8 mg/dL	0 Participants n=30 Participants
INR INR ≤ 3	10 Participants n=30 Participants
INR INR > 3	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: From baseline to 48 hours or discharge

Population: Participants with evaluable baseline and follow-up (48-hour or discharge) CT angiography assessments; one participant was excluded from analysis due to missing 48-hour CT imaging.

Outcome measures

Outcome measures
Measure	Vertex Pulmonary Embolectomy System n=9 Participants Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio	-0.4 Ratio Standard Deviation 0.3

PRIMARY outcome

Timeframe: Within 48 hours of procedure

Population: Patients presenting with clinical signs and symptoms of acute pulmonary embolism

A composite of: Device-related death within 48 hours Major bleeding within 48 hours Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury

Outcome measures

Outcome measures
Measure	Vertex Pulmonary Embolectomy System n=10 Participants Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Major Adverse Events (MAEs) Participants with ≥1 MAE	0 Participants
Major Adverse Events (MAEs) Participants without any MAE	10 Participants

Adverse Events

Vertex Pulmonary Embolectomy System

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vertex Pulmonary Embolectomy System n=10 participants at risk Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Blood and lymphatic system disorders Drop in hemoglobin	10.0% 1/10 • From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours) Adverse events were collected according to the clinical investigation plan. Major adverse events included device-related death, major bleeding, and device-related adverse events (clinical deterioration, pulmonary vascular injury, and cardiac injury). Device-relatedness was determined by the investigator. Safety endpoints were assessed within 48 hours (± 8 hours) and through 30 days (± 3 days) post-procedure, as specified in the protocol.

Other adverse events

Other adverse events
Measure	Vertex Pulmonary Embolectomy System n=10 participants at risk Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System Vertex Pulmonary Embolectomy System: Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Renal and urinary disorders Kidney injury	10.0% 1/10 • From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours) Adverse events were collected according to the clinical investigation plan. Major adverse events included device-related death, major bleeding, and device-related adverse events (clinical deterioration, pulmonary vascular injury, and cardiac injury). Device-relatedness was determined by the investigator. Safety endpoints were assessed within 48 hours (± 8 hours) and through 30 days (± 3 days) post-procedure, as specified in the protocol.
Injury, poisoning and procedural complications Inguinal hematoma	10.0% 1/10 • From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours) Adverse events were collected according to the clinical investigation plan. Major adverse events included device-related death, major bleeding, and device-related adverse events (clinical deterioration, pulmonary vascular injury, and cardiac injury). Device-relatedness was determined by the investigator. Safety endpoints were assessed within 48 hours (± 8 hours) and through 30 days (± 3 days) post-procedure, as specified in the protocol.
Blood and lymphatic system disorders Drop in hemoglobin	10.0% 1/10 • From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours) Adverse events were collected according to the clinical investigation plan. Major adverse events included device-related death, major bleeding, and device-related adverse events (clinical deterioration, pulmonary vascular injury, and cardiac injury). Device-relatedness was determined by the investigator. Safety endpoints were assessed within 48 hours (± 8 hours) and through 30 days (± 3 days) post-procedure, as specified in the protocol.
Infections and infestations Pneumonia	10.0% 1/10 • From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours) Adverse events were collected according to the clinical investigation plan. Major adverse events included device-related death, major bleeding, and device-related adverse events (clinical deterioration, pulmonary vascular injury, and cardiac injury). Device-relatedness was determined by the investigator. Safety endpoints were assessed within 48 hours (± 8 hours) and through 30 days (± 3 days) post-procedure, as specified in the protocol.

Additional Information

Karlee Doolittle

Jupiter Endovascular

Phone: 707-291-4074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60