Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
Previous Study | Return to List | Next Study

Feasibility of Endovascular Repair of Ascending Aortic Pathologies (PS-IDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03322033
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending thoracic aortic pathologies including type A aortic dissection, who are suitable for endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).

Condition or disease Intervention/treatment Phase
Dissection of Thoracic Aorta Device: Valiant PS-IDE Stent Graft Not Applicable

Detailed Description:

The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies including type A aortic dissection, retrograde type A aortic dissection, who are suitable for endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with Dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft. For patients with type A aortic dissection, the investigators expect to reroute the blood to the true lumen by covering the proximal tear. In patients with retrograde type A aortic dissection, there might or might not be additional tears in the ascending aorta. If they are tears in ascending aorta, these dissections behave similarly like a type A aortic dissection, in which all the tears in the ascending aorta need to be covered. If the proximal tear is only in the descending thoracic aorta, these patients will require coverage in the ascending aorta with the stent graft along with coverage of proximal tear in the descending thoracic aorta using Valiant stent graft.

Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : January 15, 2027
Estimated Study Completion Date : January 15, 2028

Arm Intervention/treatment
Experimental: Type A Dissection
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Device: Valiant PS-IDE Stent Graft
Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System




Primary Outcome Measures :
  1. Freedom from early death [ Time Frame: 30 days ]
    Freedom from early death at 30-days post-procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In order to qualify for this physician-sponsored Investigational Device Exemption, the patients would have to meet the entire entry criteria listed below, sign a consent approved by the FDA and IRB, and agrees to follow-up according to the study protocol.

    • Patient must have a type A thoracic aortic dissection, retrograde type A thoracic aortic dissection of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered a candidate for endovascular repair;

      • The proximal and distal landing zones for placement of graft should be at least 1 cm.
      • The proximal landing zone will allow placement of the stent graft as to not inhibit valvular function, occlude a coronary ostium or proximal bypass graft; The aortic root may be dissected, but the proximal tear site must be at least 1cm from the STJ (and within the above listed size criteria).
      • Distal landing zone must allow for continued perfusion of critical cerebral vessels;
      • The aorta as measured adventitial wall to adventitial wall must be greater than 28 mm and no more than 44 mm maximum diameter at both the proximal and distal landing zone.
      • The patient must be high-risk surgical candidate according to the following established criteria: ASA score of IV.

Exclusion Criteria:

  • Pregnant or pediatric patients (younger than 21 years of age);
  • Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis;
  • Patients with allergies to the stent graft material;
  • Patients or their legally authorized representative (LAR) who do not sign the informed consent;
  • Patients with expected survival less than one year due to a condition other than the ascending aortic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322033


Contacts
Layout table for location contacts
Contact: Megan C White, BA 469-814-4720 megan.white1@bswhealth.org

Locations
Layout table for location information
United States, Texas
Baylor Scott & White The Heart Hospital Recruiting
Plano, Texas, United States, 75035
Contact: Pauline Matheri       pauline.matheri@bswhealth.org   
Contact: Megan White       megan.white1@bswhealth.org   
Sponsors and Collaborators
Baylor Research Institute
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: William Brinkman, MD Cardiac Surgery Specialists
Layout table for additonal information
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03322033    
Other Study ID Numbers: G170196
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes