Clinical trial NCT05077657: Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
Official title: Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Lead sponsor: Saranas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Proxima CRO
name: Cardiovascular Research Foundation, New York
First posted: 2021-10-14
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) via Impella® and transfemoral arterial approach will be enrolled. The Saranas Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

Brief summary: The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).

Detailed description: To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
* The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:

* Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
* Active bleeding
* Incapacity to access safely femoral artery or femoral vein
* Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
* Anemia (Hgb \<9 g/dL), thrombocytopenia (Plt \<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
* Active infection not controlled with antibiotic therapy
* Currently pregnant or women of child-bearing potential without documented negative pregnancy test
* Estimated life expectancy \< 24 hours
* Patient is in cardiogenic shock at the time of enrollment

Primary outcomes:
measure: Incidence of access site related BARC type III or V bleeding
timeFrame: Within 24 hours
Secondary outcomes:
measure: Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator
timeFrame: Within 24 hours
measure: Incidence of all BARC type III or V bleeding
timeFrame: Within 24 hours
Other outcomes:
measure: Access site related bleeding complications
timeFrame: Within 24 hours
measure: Access site related vascular complications
timeFrame: Within 24 hours
measure: Access site related blood transfusions
timeFrame: Within 24 hours
measure: Non-access site related bleeding complications
timeFrame: Within 24 hours
measure: Non-access site related vascular complications
timeFrame: Within 24 hours
measure: Non-access site related blood transfusions
timeFrame: Within 24 hours
measure: All blood transfusions
timeFrame: Within 24 hours
measure: Hemoglobin drop
timeFrame: Within 24 hours
measure: Death
timeFrame: Within 24 hours
measure: Device and procedure-related adverse events
timeFrame: Within 24 hours
measure: Serious adverse events
timeFrame: Within 24 hours
measure: Serious adverse device effects
timeFrame: Within 24 hours
Locations:
city: Phoenix
country: United States
facility: St. Joseph Hospital / Arizona Heart
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center / PIMA Heart
state: Arizona
city: Gary
country: United States
facility: Methodist Hospitals
state: Indiana
city: Dearborn
country: United States
facility: Ascension - St. John
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Edison
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell / Lenox Hill & Staten Island
state: New York
city: Houston
country: United States
facility: Memorial Hermann / UTH
state: Texas
city: Houston
country: United States
facility: St. Luke's / Texas Heart
state: Texas
city: Kingwood
country: United States
facility: Memorial Hermann NE / TCR Institute
state: Texas
Study officials:
affiliation: Henry Ford Hospital
name: Mir Basir, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Gagnon Cardiovascular Institute - Morristown Medical Center
name: Philippe Généreux, MD
role: PRINCIPAL_INVESTIGATOR
References: