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

Primary Purpose

Aortic Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exclusion of thoracoabdominal lesion

Endovascular Device Implant

About this trial

This is an interventional treatment trial for Aortic Disease focused on measuring Thoracoabdominal lesions

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Long Beach Memorial Medical Center, Memorial Heart & Vascular InstituteRecruiting
LAC Harbor-UCLA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Device Implantation

Arm Description

Endoluminal exclusion of thoracoabdominal lesion

Outcomes

Primary Outcome Measures

All cause mortality

Early (at 30-days) death

Additional endovascular procedure

Re-intervention

Conversion to open repair

Surgical conversion

Stroke

All cause mortality

Additional endovascular procedure

Re-intervention

Conversion to open repair

Surgical conversion

Secondary Outcome Measures

Vessel complications

Includes dissection, thrombosis, embolization of vessels, malperfusion of branch vessels

Technical observations

Includes loss of patency, endoleaks, twisting, kinking, fracture of stent graft, migration and separation of components

Composite of myocardial infarction, organ failure, sepsis

Full Information

NCT ID

NCT02524834

First Posted

July 31, 2015

Last Updated

March 27, 2023

Sponsor

Rodney A. White, M.D.

Collaborators

Long Beach Memorial Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02524834

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2030 (Anticipated)

Study Completion Date

July 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rodney A. White, M.D.

Collaborators

Long Beach Memorial Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Disease

Keywords

Thoracoabdominal lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endovascular Device Implantation

Arm Type

Experimental

Arm Description

Endoluminal exclusion of thoracoabdominal lesion

Intervention Type

Procedure

Intervention Name(s)

Exclusion of thoracoabdominal lesion

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Endovascular Device Implant

Intervention Description

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

Primary Outcome Measure Information:

Title

All cause mortality

Description

Early (at 30-days) death

Time Frame

30 days post intervention

Title

Additional endovascular procedure

Description

Re-intervention

Time Frame

At 30 days

Title

Conversion to open repair

Description

Surgical conversion

Time Frame

At 30 days

Title

Stroke

Time Frame

At 30 days

Title

All cause mortality

Time Frame

At 1 year post procedure

Title

Additional endovascular procedure

Description

Re-intervention

Time Frame

At 1 year

Title

Conversion to open repair

Description

Surgical conversion

Time Frame

At 1 year

Secondary Outcome Measure Information:

Title

Vessel complications

Description

Includes dissection, thrombosis, embolization of vessels, malperfusion of branch vessels

Time Frame

Up to 5 years post intervention

Title

Technical observations

Description

Includes loss of patency, endoleaks, twisting, kinking, fracture of stent graft, migration and separation of components

Time Frame

Up to 5 years post intervention

Title

Composite of myocardial infarction, organ failure, sepsis

Time Frame

Up tp 5 years post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rodney A White, MD

Phone

310 963-5230

rawhite@ucla.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ankur Gupta, MD

Phone

650- 224-8977

agupta2@memorialcare.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodney A White, MD

Organizational Affiliation

Los Angeles BioMedical Research Institute, Vascular Surgery and Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Long Beach Memorial Medical Center, Memorial Heart & Vascular Institute

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rodney A White, MD

Phone

310-963-5230

rawhite@ucla.edu

First Name & Middle Initial & Last Name & Degree

Ankur Gupta, MD

Phone

650 224 8977

agupta2@memorialcare.org

First Name & Middle Initial & Last Name & Degree

Ankur Gupta, MD

First Name & Middle Initial & Last Name & Degree

Raffat Jaber, MD

Facility Name

LAC Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rodney White, MD

Phone

310-963-5230

rawhite@ucla.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth Burrola, BS

Phone

310 222-3612

lburrola@labiomed.org

First Name & Middle Initial & Last Name & Degree

Rodney A White, MD

First Name & Middle Initial & Last Name & Degree

Mark Archie, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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