Clincosm LogoSign in Get a demo

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04149535
Collaborator
(none)
3,000
Enrollment
57
Locations
2
Arms
23.8
Actual Duration (Months)
52.6
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Condition or Disease Intervention/Treatment Phase
  • Device: Sentinel® Cerebral Protection System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
Actual Study Start Date :
Feb 7, 2020
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAVR with Sentinel

Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.

Device: Sentinel® Cerebral Protection System
cerebral embolic protection system
No Intervention: TAVR without Sentinel

Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

Outcome Measures

Primary Outcome Measures

  1. The rate of stroke through 72 hours post TAVR procedure or discharge (whichever comes first) [<=72 hours]

    All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access

  • Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.

  • Subject (or legal representative) provides written informed consent.

Exclusion Criteria:

  • Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.

  • Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.

  • Subject has compromised blood flow to the right upper extremity.

  • Subject has access vessels with excessive tortuosity.

  • Subject has uncorrected bleeding disorders.

  • Subject is contraindicated for anticoagulant and antiplatelet therapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tucson Medical Center Tucson Arizona United States 85712
2 Cedars Sinai Medical Center Los Angeles California United States 90048
3 University of California, Davis Medical Center Sacramento California United States 95817
4 Kaiser Foundation Hospital - San Francisco San Francisco California United States 94118
5 Los Robles Regional Medical Center Thousand Oaks California United States 91360
6 South Denver Cardiology Associates PC and Swedish medical center Littleton Colorado United States 80120
7 Hartford Hospital Hartford Connecticut United States 06102
8 Medstar Washington Hospital Center Washington District of Columbia United States 20010
9 Intercoastal Medical Group Sarasota Florida United States 34239
10 Tampa General Hospital Tampa Florida United States 33606
11 Piedmont Hosptial Atlanta Georgia United States 30309
12 Wellstar Marietta Georgia United States 30060
13 St. Johns Hospital Springfield Illinois United States 62701
14 Community Munster Munster Indiana United States 46321
15 Mercy Hospital Medical Center Des Moines Iowa United States 50314
16 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
17 Massachusetts General Hospital Boston Massachusetts United States 02114
18 Lahey Clinic Hospital Burlington Massachusetts United States 01805
19 Sparrow Hospital Lansing Michigan United States 48912
20 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
21 Research Medical Center Kansas City Missouri United States 64132
22 Creighton - Bergan Cardiology Omaha Nebraska United States 68124
23 Englewood Medical Center Englewood New Jersey United States 07631
24 Jersey Shore University Medical Center Neptune New Jersey United States 98374
25 Kaleida Health Buffalo New York United States 14213
26 North Shore University Hospital Manhasset New York United States 11030
27 NYU Winthrop Mineola New York United States 11501
28 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
29 Cleveland Clinic Foundation Cleveland Ohio United States 44195
30 Oregon Health Sciences University Portland Oregon United States 97239
31 Lankenau Wynnewood Pennsylvania United States 19096
32 Baptist Memorial Memphis Tennessee United States 38120
33 Centennial Medical Center Nashville Tennessee United States 37203
34 Vanderbilt Nashville Tennessee United States 37323
35 Heart Hospital of Austin Austin Texas United States 78705
36 Baylor Heart and Vascular Dallas Texas United States 75226
37 The Methodist Hospital Houston Texas United States 77030
38 The Heart Hospital Baylor Plano Plano Texas United States 75093
39 Baylor Scott and White Round Rock Texas United States 78665
40 Methodist Healthcare System of San Antonio dba Methodist Hospital San Antonio Texas United States 78229
41 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
42 Monash Medical Center Clayton Victoria Australia 3168
43 The Prince Charles Hospital Chermside Australia 4032
44 Aarhus University Hospital Aarhus Denmark 8200
45 Aarhus University Hospital Aarhus Denmark DK-8200
46 Rigshospitalet København Denmark 2100
47 CHU La Timone Hospital Marseille France 13005
48 Clinique Pasteur Toulouse France 31076
49 Heart Center Leipzig Bad Segeberg Germany 23795
50 Herzzentrum Dresden GmbH Dresden Germany D-01307
51 University Hospital Frankfurt Frankfurt Germany 60590
52 Universitaetsklinikum Schleswig-Holstein Lübeck Germany D-23538
53 LMU Klinikum der Universität München Münich Germany 81377
54 Universitaetsklinikum Ulm Ulm Germany 89081
55 Policlinico San Donato San Donato Milanese Italy 20097
56 Maria Cecilia Hospital SPA Cotignola Italy 48010
57 Fondazione Centro San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Principal Investigator: Samir Kapadia, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT04149535
Other Study ID Numbers:
  • S2453
First Posted:
Nov 4, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Jul 28, 2022