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

NCT05133713 | Unknown

• 1 other identifier: STUDY00000091
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.

Conditions

Pulmonary Embolism; Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Ventilation-perfusion mismatch

  Mismatch on ventilation-perfusion scintigraphy per Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria

  6 months

Secondary Outcomes (8)

• 6-minute walk distance

  30 days

• 6-minute walk distance

  6 months

• Hospital length of stay

  Up to 30 days

• Dyspnea questionnaire

  up to 72 hours

• Dyspnea questionnaire

  30 days

Study Arms (2)

Catheter directed thrombectomy

Device: Catheter directed therapy; Drug: Systemic anticoagulation

Systemic anticoagulation

Drug: Systemic anticoagulation

Interventions

Catheter directed therapy DEVICE

Thrombectomy

Catheter directed thrombectomy

Systemic anticoagulation DRUG

Conservative therapy

Catheter directed thrombectomy; Systemic anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring treatment for acute pulmonary embolism.

You may qualify if:

• Age \>18 years
• Clinical signs and symptoms consistent with acute PE
• Echocardiogram, CT pulmonary angiogram (CTPA) or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
• Scheduled for PE treatment with catheter directed therapy and systemic anticoagulation or anticoagulation alone per the investigator's discretion
• 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

You may not qualify if:

• Unable to be anticoagulated with heparin or alternative therapy
• Diagnosis with a minor PE without signs of right ventricular (RV) dysfunction
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
• 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)
• Life expectancy \<6 months, as determined by the Investigator

Sponsors & Collaborators

• University of Arizona: lead
• Inari Medical: collaborator

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85721, United States

RECRUITING

Related Publications (6)

• Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.

  PMID: 10227218 BACKGROUND

• Casazza F, Becattini C, Bongarzoni A, Cuccia C, Roncon L, Favretto G, Zonzin P, Pignataro L, Agnelli G. Clinical features and short term outcomes of patients with acute pulmonary embolism. The Italian Pulmonary Embolism Registry (IPER). Thromb Res. 2012 Dec;130(6):847-52. doi: 10.1016/j.thromres.2012.08.292. Epub 2012 Aug 24.

  PMID: 22921592 BACKGROUND

• Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011 Jan 27;364(4):351-60. doi: 10.1056/NEJMra0910203. No abstract available.

  PMID: 21268727 BACKGROUND

• Kahn SR, Akaberi A, Granton JT, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Hernandez P, Aaron SD, Hirsch AM. Quality of Life, Dyspnea, and Functional Exercise Capacity Following a First Episode of Pulmonary Embolism: Results of the ELOPE Cohort Study. Am J Med. 2017 Aug;130(8):990.e9-990.e21. doi: 10.1016/j.amjmed.2017.03.033. Epub 2017 Apr 8.

  PMID: 28400247 BACKGROUND

• Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. doi: 10.1378/chest.129.1.192.

  PMID: 16424432 BACKGROUND

• Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.

  PMID: 27932051 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hypertension

Central Study Contacts

Carol Stuehm

CONTACT

520-626-8318; carols@email.arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

US (1)