Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Pulmonary Embolism Clinical Trial

Official title:

STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798261
• Other study ID #: 18135
• Status: Recruiting
• Start date: June 25, 2021
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Penumbra Inc.
• Contact: Joanne Krasnoff
• Phone: 650-455-4462
• Email: jkrasnoff[@]penumbrainc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less

2. RV/LV ratio = 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram

3. Frontline endovascular treatment with the Indigo Aspiration System per IFU

4. Patient is = 18 years of age

5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Exclusion Criteria:

1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)

2. Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study

3. Known serious, uncontrolled sensitivity to radiographic agents

4. Life expectancy < 180 days

5. Patients on ECMO

6. Pregnant patients

7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies

8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Indigo Aspiration System
Indigo Aspiration System

Locations

Country	Name	City	State
Italy	Ospedale Misericordia	Grosseto
Netherlands	Leids Universitair Medisch Centrum	Leiden
Poland	Krakowski Szpital Specjalistyczny sw. Jana Pawla II	Kraków
Poland	Europejskie Centrum Zdrowia Otwock	Otwock
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warszawa
Portugal	Hospital de Santa Cruz	Carnaxide
Spain	Hospital Universitario Virgen de la Nieves	Granada
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
United Kingdom	Royal Sussex County Hospital	Brighton	Sussex
United Kingdom	University Hospital of Wales	Cardiff	Wales
United States	Lovelace Health System	Albuquerque	New Mexico
United States	University Hospital Augusta	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Blake Medical Center/Nova Clinical Research	Bradenton	Florida
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Cooper Health System	Camden	New Jersey
United States	Christ Hospital	Cincinnati	Ohio
United States	TriHealth Good Samaritan Hospital	Cincinnati	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	KUMC	Kansas City	Kansas
United States	Radiology and Imaging Specialists	Lakeland	Florida
United States	Long Beach Medical Center	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Baptist Health Miami Cardiac and Vascular Institute	Miami	Florida
United States	Jackson Memorial Hospital	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Bellevue Hospital Center	New York	New York
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Sentara Norfolk General	Norfolk	Virginia
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Miriam Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	St. Francis Hospital and Heart Center	Roslyn	New York
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Sharp Memorial Hospital	San Diego	California
United States	LSU Health Sciences Center	Shreveport	Louisiana
United States	Staten Island University Hospital	Staten Island	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	St. Joseph Hospital - BayCare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Composite of major adverse events	A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury	48 hours
Primary	Performance: Change in RV/LV Ratio	Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)	48 hours post-procedure
Secondary	Quality of Life assessed via PEmb-QoL	Self-assessment of PE related complaints and daily living limitations (including work and social)	90 days post-procedure
Secondary	Quality of Life assessed via EQ-5D-5L	Self-assessment of activities of daily living	90 days post-procedure
Secondary	Functional outcome assessed NYHA	Physician assessment of heart failure symptoms and activity level	90 days post-procedure
Secondary	Functional outcome assessed via 6MWT	Walking distance over a 6 minute period to assess functional capacity	90 days post-procedure
Secondary	Perceived dyspnea assessed via Borg Scale	Category rating scale to measure perceived dyspnea	90 days post-procedure
Secondary	Incidence of device related SAE(s)		365 days
Secondary	Any-cause mortality		Within 30 days
Secondary	Symptomatic PE recurrence		Within 30 days