CLEANer Aspiration for Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-03

Study Completion Date

2027-09-02

Brief Summary

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To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

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Detailed Description

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Conditions

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Pulmonary Embolism Acute Pulmonary Embolism Cardiovascular Diseases Venous Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mechanical Thrombectomy via Cleaner Pro

Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.

Group Type EXPERIMENTAL

Cleaner Pro Thrombectomy System

Intervention Type DEVICE

The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.

Interventions

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Cleaner Pro Thrombectomy System

The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.

Intervention Type DEVICE

Other Intervention Names

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Cleaner Vac Thrombectomy System

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age at the time of consent
* Clinical signs, symptoms, and presentation consistent with acute PE
* Onset of PE symptoms occurred within 14 days of presentation
* Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
* RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9

Exclusion Criteria

* tPA use within 14 days prior to baseline CTA
* Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
* Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
* History of severe or chronic pulmonary hypertension
* FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90%
* Hematocrit \<28%
* Platelets \<100,000/µL
* Serum creatinine \>1.8 mg/dL
* INR \>3
* aPTT (or PTT) \>50 seconds on no anticoagulation
* History of heparin-induced thrombocytopenia (HIT)
* Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
* Recent (within one month) history of active bleeding from a major organ
* Absolute contraindication to anticoagulation
* Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
* Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
* Cardiovascular or pulmonary surgery within last 7 days
* Cancer which requires active chemotherapy
* Known serious, uncontrolled sensitivity to radiographic agents
* Life expectancy \<90 days, as determined by investigator
* Female who is pregnant
* Intracardiac thrombus
* Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
* Simultaneous participation in another investigational study
* Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
* Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No