Aortic DiseaseNCT02524834
Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis
A study testing Exclusion of thoracoabdominal lesion and Endovascular Device Implant in people with Aortic Disease, run by Rodney A. White, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Aortic Disease
- What is being tested?
- Exclusion of thoracoabdominal lesion and Endovascular Device Implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2015to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Beach Memorial Medical Center, Memorial Heart & Vascular Institute
Long Beach, California, 90806
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Disease
- Being tested
- Exclusion of thoracoabdominal lesion, Endovascular Device Implant
- Keywords
- Thoracoabdominal lesions
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusion of thoracoabdominal lesionProcedure or surgery
Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
Endovascular Device ImplantDevice
Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Device Implantation | Experimental | Endoluminal exclusion of thoracoabdominal lesion Receives: Procedure: Exclusion of thoracoabdominal lesion; Device: Endovascular Device Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Early (at 30-days) death
Measured: 30 days post intervention
Additional endovascular procedure
Re-intervention
Measured: At 30 days
Conversion to open repair
Surgical conversion
Measured: At 30 days
Stroke
Stroke
Measured: At 30 days
All cause mortality
Death
Measured: At 1 year post procedure
Additional endovascular procedure
Re-intervention
Measured: At 1 year
Conversion to open repair
Surgical conversion
Measured: At 1 year
Secondary outcomes (3)
Vessel complications
Includes dissection, thrombosis, embolization of vessels, malperfusion of branch vessels
Measured: Up to 5 years post intervention
Technical observations
Includes loss of patency, endoleaks, twisting, kinking, fracture of stent graft, migration and separation of components
Measured: Up to 5 years post intervention
Composite of myocardial infarction, organ failure, sepsis
Includes Myocardial Infarction, organ failure and sepsis
Measured: Up tp 5 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start29 May 2015
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Why it stopped: Unable to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodney A. White, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Long Beach Memorial Medical Center
- Responsible party
- Sponsor-investigator, Rodney A. White, MD, MemorialCare Health System
- Investigators
- Rodney A White, MD, Principal investigator, Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524834
- Sponsor's protocol ID
- PSIDE:Thoracoabdominal Lesions
- Status last verified
- May 2025
- First submitted
- 31 Jul 2015
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis
- ClinicalTrials.gov ID
- NCT02524834
- Acronym / sponsor ID
- PSIDE:Thoracoabdominal Lesions
- Conditions
- Aortic Disease
- Keywords
- Thoracoabdominal lesions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rodney A. White, MDUniversity, hospital or other
- Collaborators
- Long Beach Memorial Medical Center
- Study start
- 29 May 2015 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Device Implantation | Experimental | Procedure: Exclusion of thoracoabdominal lesion, Device: Endovascular Device ImplantEndoluminal exclusion of thoracoabdominal lesion |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Patients must have a distal fixation iliac artery diameter greater than 2 cm in length and 12-28 mm in diameter;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusion of thoracoabdominal lesionEndovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft | Procedure or surgery | Endovascular Device Implantation |
| Endovascular Device ImplantEndovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft | Device | Endovascular Device Implantation |
Primary outcome
All cause mortality
Time frame: 30 days post intervention
Early (at 30-days) death
Additional endovascular procedure
Time frame: At 30 days
Re-intervention
Conversion to open repair
Time frame: At 30 days
Surgical conversion
Stroke
Time frame: At 30 days
Stroke
All cause mortality
Time frame: At 1 year post procedure
Death
Additional endovascular procedure
Time frame: At 1 year
Re-intervention
Conversion to open repair
Time frame: At 1 year
Surgical conversion
3 secondary outcomes
Vessel complications
Time frame: Up to 5 years post intervention
Technical observations
Time frame: Up to 5 years post intervention
Composite of myocardial infarction, organ failure, sepsis
Time frame: Up tp 5 years post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney A White, MD principal investigator
Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusion of thoracoabdominal lesion and Endovascular Device Implant in people with Aortic Disease, run by Rodney A. White, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 30 days post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.