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

NCT02524834 | Withdrawn FDA Device

• 1 other identifier: PSIDE:Thoracoabdominal Lesions
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Disease

Keywords

Thoracoabdominal lesions

Outcome Measures

Primary Outcomes (7)

• 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

• Stroke

  Stroke

  At 30 days

• All cause mortality

  Death

  At 1 year post procedure

• Additional endovascular procedure

  Re-intervention

  At 1 year

• Conversion to open repair

  Surgical conversion

  At 1 year

Secondary Outcomes (3)

• Vessel complications

  Up to 5 years post intervention

• Technical observations

  Up to 5 years post intervention

• Composite of myocardial infarction, organ failure, sepsis

  Up tp 5 years post intervention

Study Arms (1)

Endovascular Device Implantation

EXPERIMENTAL

Endoluminal exclusion of thoracoabdominal lesion

Procedure: Exclusion of thoracoabdominal lesion; Device: Endovascular Device Implant

Interventions

Exclusion of thoracoabdominal lesion PROCEDURE

Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft

Endovascular Device Implantation

Endovascular Device Implant DEVICE

Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft

Endovascular Device Implantation

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rodney A. White, MD: lead
• Long Beach Memorial Medical Center: collaborator

Study Sites (1)

Long Beach Memorial Medical Center, Memorial Heart & Vascular Institute

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rodney A White, MD

  Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Vascular Surgery, Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 17, 2015
• Study Start: May 29, 2015
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)