Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System

NCT05077657 | Completed FDA Device

• 1 other identifier: PVP012
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 11

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).

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Incidence of access site related BARC type III or V bleeding

  Within 24 hours

Secondary Outcomes (2)

• Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator

  Within 24 hours

• Incidence of all BARC type III or V bleeding

  Within 24 hours

Other Outcomes (12)

• Access site related bleeding complications

  Within 24 hours

• Access site related vascular complications

  Within 24 hours

• Access site related blood transfusions

  Within 24 hours

Study Arms (1)

Single-Arm

This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).

Device: Early Bird® Bleed Monitoring System; Device: Impella®

Interventions

Early Bird® Bleed Monitoring System DEVICE

The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.

Single-Arm

Impella® DEVICE

Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saranas, Inc.: lead
• Proxima CRO: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (11)

St. Joseph Hospital / Arizona Heart

Phoenix, Arizona, 85013, United States

Location

Tucson Medical Center / PIMA Heart

Tucson, Arizona, 85719, United States

Location

Methodist Hospitals

Gary, Indiana, 46402, United States

Location

Ascension - St. John

Dearborn, Michigan, 48124, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hackensack Meridian Health

Edison, New Jersey, 08837, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Northwell / Lenox Hill & Staten Island

New Hyde Park, New York, 11042, United States

Location

Memorial Hermann / UTH

Houston, Texas, 77030, United States

Location

St. Luke's / Texas Heart

Houston, Texas, 77030, United States

Location

Memorial Hermann NE / TCR Institute

Kingwood, Texas, 77021, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mir Basir, DO

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• Philippe Généreux, MD

  Gagnon Cardiovascular Institute - Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: November 29, 2021
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (11)