An interventional study of Exclusion of thoracoabdominal lesion and Endovascular Device Implant in Aortic Disease, sponsored by Rodney A. White, MD. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Rodney A. White, MD · Not applicable, Interventional, and Treatment
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.
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.
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
Browse Aortic Diseases studies →Rodney A. White, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoluminal exclusion of thoracoabdominal lesion
Procedure: Exclusion of thoracoabdominal lesion · Device: Endovascular Device Implant
Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
All cause mortality
Early (at 30-days) death
Time frame: 30 days post intervention
Additional endovascular procedure
Re-intervention
Time frame: At 30 days
Conversion to open repair
Surgical conversion
Time frame: At 30 days
Stroke
Stroke
Time frame: At 30 days
All cause mortality
Death
Time frame: At 1 year post procedure
Additional endovascular procedure
Re-intervention
Time frame: At 1 year
Conversion to open repair
Surgical conversion
Time frame: At 1 year
Vessel complications
Includes dissection, thrombosis, embolization of vessels, malperfusion of branch vessels
Time frame: Up to 5 years post intervention
Technical observations
Includes loss of patency, endoleaks, twisting, kinking, fracture of stent graft, migration and separation of components
Time frame: Up to 5 years post intervention
Composite of myocardial infarction, organ failure, sepsis
Includes Myocardial Infarction, organ failure and sepsis
Time frame: Up tp 5 years post intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2015 to primary completion in Feb 2025, 116 months.
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This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Rodney A. White, MD