Ventilation and Perfusion Scan in Pulmonary Embolism Following Catheter Directed Thrombectomy Versus Anticoagulation Alone

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT05133713
• Date of registration: 01/11/2021
• Prospective Registration: Yes
• Primary sponsor: University of Arizona
• Public title: Ventilation and Perfusion Scan in Pulmonary Embolism Following Catheter Directed Thrombectomy Versus Anticoagulation Alone VQPE
• Scientific title: Ventilation and Perfusion Imaging in Acute Pulmonary Embolism Following Catheter Directed Aspiration Thrombectomy Versus Conservative Therapy Alone: A Pilot Study
• Date of first enrolment: April 1, 2022
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT05133713
• Study type: Observational [Patient Registry]

Countries of recruitment

United States

Contacts

• Name: Carol Stuehm

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age >18 years

2. Clinical signs and symptoms consistent with acute PE

3. Echocardiogram, CT pulmonary angiogram (CTPA) or pulmonary angiographic evidence of
proximal filling defect in at least one main or lobar pulmonary artery

4. Scheduled for PE treatment with catheter directed therapy and systemic anticoagulation
or anticoagulation alone per the investigator's discretion

5. Signs of respiratory failure including a. arterial blood saturation <90%, or b.
partial arterial oxygen pressure <60 mmHg, or c. persistent tachypnea with respiratory
rates > 20/min

Exclusion Criteria:

1. Unable to be anticoagulated with heparin or alternative therapy

2. Diagnosis with a minor PE without signs of right ventricular (RV) dysfunction

3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion,
cannot be adequately pre-treated

4. Imaging evidence or other evidence that suggests, in opinion of the Investigator, the
patient is not appropriate for mechanical thrombectomy intervention (e.g., inability
to navigate to target location or predominately chronic clot)

5. Life expectancy <6 months, as determined by the Investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Pulmonary Embolism

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Drug: Systemic anticoagulation

Device: Catheter directed therapy

Primary Outcome(s)

Ventilation-perfusion mismatch [Time Frame: 6 months]

Secondary Outcome(s)

Quality of life questionnaire [Time Frame: 6 months]

Quality of life questionnaire [Time Frame: 30 days]

6-minute walk distance [Time Frame: 6 months]

Dyspnea questionnaire [Time Frame: 30 days]

Dyspnea questionnaire [Time Frame: 6 months]

6-minute walk distance [Time Frame: 30 days]

Dyspnea questionnaire [Time Frame: up to 72 hours]

Hospital length of stay [Time Frame: Up to 30 days]

Secondary ID(s)

STUDY00000091

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Inari Medical