CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
EmStop Inc
Study ID
NCT07276711
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis
  • Aortic Valve Disease
  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EmStop Embolic Protection System — DEVICE
    EmStop Embolic Protection System used during TAVR procedure
  • Boston Scientific Sentinel — DEVICE
    Sentinel device used during TAVR procedure

Study Details

The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.

Key Dates

First listed
Dec 11, 2025
Start date
May 12, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
663 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EmStop System
  • Active Comparator: Boston Scientific Sentinel device

Primary Outcome Measure

Non-Inferiority [ Time Frame: Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Saibal Kar, MD (PRINCIPAL_INVESTIGATOR)
Morton Plant Hospital | BayCare HealthClearwaterFlorida33756
Joshua Rovin, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Medical CenterNew OrleansLouisiana70121
James S Jenkins, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health | Michigan MedicineAnn ArborMichigan48109
Paul M Grossman, MD (PRINCIPAL_INVESTIGATOR)
Mission HealthAshevilleNorth Carolina28801
Michaeal Chenier, MD (PRINCIPAL_INVESTIGATOR)
Monument Health Heart and Vascular InstituteRapid CitySouth Dakota57701
Joseph Tuma, MD (PRINCIPAL_INVESTIGATOR)
Methodist Research InstituteSan AntonioTexas78229
Jorge Alvarez, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Thousand Oaks, CA

By research site
Los Robles Regional Medical Center· Thousand Oaks, CAMorton Plant Hospital | BayCare Health· Clearwater, FLOchsner Medical Center· New Orleans, LAUniversity of Michigan Health | Michigan Medicine· Ann Arbor, MIMission Health· Asheville, NCMonument Health Heart and Vascular Institute· Rapid City, SD

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