Safe Surveillance of PCI Under Mechanical Circulatory Sup... | NCT05077657

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2021Actual

Primary Completion Date

Dec 19, 2023Actual

Completion Date

Dec 19, 2023Actual

First Submitted Date

Oct 1, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2024

Last Update Posted Date

Feb 16, 2024Actual

Name	Class
Proxima CRO	INDUSTRY
Cardiovascular Research Foundation, New York	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of access site related BARC type III or V bleeding		Within 24 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Access site related bleeding complications	Safety Endpoint	Within 24 hours
Access site related vascular complications	Safety Endpoint	Within 24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mir Basir, DO	Henry Ford Hospital	Principal Investigator
Philippe Généreux, MD	Gagnon Cardiovascular Institute - Morristown Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph Hospital / Arizona Heart		Phoenix	Arizona	85013	United States
Tucson Medical Center / PIMA Heart

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases