Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis

Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis

This is an early feasibility study that investigates the outcome of selected patients with complex thoracoabdominal aortic lesions who are suitable for endovascular (within the vessel) repair with a physician-modified Medtronic Thoracic Valiant stent graft. The Medtronic Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end prosthesis which is modified/customized by the Investigators to fit the patient's anatomy. The device is constructed by making a taper in the larger proximal thoracic device and attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral vessels are sutured to holes made in the tapered section. The modified Valiant stent graft is advanced to the lesion site endoluminally via the iliac/femoral artery. Access for delivery of extensions to the device will be delivered through the left subclavian artery. Upon deployment, the stent graft self-expands at the target location, where it is designed to exclude the lesion by restoring blood flow through the stent graft lumen.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Disease
• Intervention / Treatment: Procedure: Exclusion of thoracoabdominal lesion; Device: Endovascular Device Implant

Detailed Description

The study will be conducted with non-surgical or very high-risk patients who are considered suitable candidates for endoluminal repair and who are diagnosed with a Type IV complex thoracoabdominal aortic lesion. The total number of enrolled subjects is planned to be 15. It is a prospective evaluation of patients receiving the device to determine the proportion in whom successful implantation is achieved, as indicated by exclusion of the thoracic lesion and graft patency at implant, time of discharge, and 1, 6, and 12 months following implantation, and to determine the proportion of patients who die or experience adverse events during and after the implantation. Furthermore, the percentage of patients in whom technical and clinical success is achieved, will be determined. Patients will be followed for 5 years after the surgery in which the stent graft is implanted.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center, Memorial Heart & Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must have a Type IV complex thoracoabdominal aortic lesion and be considered candidates for endovascular repair;
• Patients must have an ileofemoral access compatible with delivery of a 25 Fr MedtronicValiant thoracic endograft;
• Patients must have a left subclavian artery anatomy compatible with 8 mm Dacron conduit to provide safe, sequential antegrade deployments of branch extensions

• Patients must have a nonaneurysmal proximal aortic segment distal to the left subclavian artery with at least 2 cm length to assure secure proximal fixation with a

  • Minimum diameter of 28 mm
  • Maximum diameter of 42mm
  • Angle less than 60° relative to axis of the aneurysm
  • Angle less than 60° relative to axis of the thoracic aorta;
• Patients must have a distal fixation iliac artery diameter greater than 2 cm in length and 12-28 mm in diameter;
• Patients must be high-risk surgical candidates 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 who fail to sign informed consent;
• Patients with expected survival less than one year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular Device Implantation; Endoluminal exclusion of thoracoabdominal lesion	Procedure: Exclusion of thoracoabdominal lesion; Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft; Device: Endovascular Device Implant; Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Early (at 30-days) death	30 days post intervention
Additional endovascular procedure	Re-intervention	At 30 days
Conversion to open repair	Surgical conversion	At 30 days
Additional endovascular procedure	Re-intervention	At 1 year
Conversion to open repair	Surgical conversion	At 1 year
Stroke	Stroke	At 30 days
All cause mortality	Death	At 1 year post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vessel complications	Includes dissection, thrombosis, embolization of vessels, malperfusion of branch vessels	Up to 5 years post intervention
Technical observations	Includes loss of patency, endoleaks, twisting, kinking, fracture of stent graft, migration and separation of components	Up to 5 years post intervention
Composite of myocardial infarction, organ failure, sepsis	Includes Myocardial Infarction, organ failure and sepsis	Up tp 5 years post intervention

Collaborators and Investigators

• Sponsor: Rodney A. White, MD
• Collaborators: Long Beach Memorial Medical Center
• Investigators: Principal Investigator: Rodney A White, MD, Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2015
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimated): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Thoracoabdominal lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases
• Other Study ID Numbers: PSIDE:Thoracoabdominal Lesions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No