Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2002-10-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
NCT00413231
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
NCT01114724
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
NCT02365467
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
NCT05479305
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
NCT03246126
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Untreated thoracic aneurysms can be life-threatening. As many as 78% of untreated patients with TAA die within 5 years after diagnosis, most often from rupture of the aneurysm. Conventional surgical treatment, either tube graft placement or patch aortoplasty, is a high risk surgical procedure. Repair of the thoracic descending aorta is performed with a thoracotomy and cross-clamping of the aorta, with or without a shunt by-pass to maintain distal perfusion.
As an alternative to conventional surgery, a less invasive endovascular procedure has been developed that may be used to treat certain aneurysms. A collapsed stent-graft, a metal stent coupled with a fabric graft, is introduced into the vasculature, advanced to the size of the aneurysm, and deployed to span the aneurysm. The device creates a new aortic lumen, excluding the aneurysm sac from blood flow while maintaining flow within the stent-graft. This less invasive technique is designed to prevent or decrease the need for open surgery, to reduce the need for blood transfusion, to decrease the use of anesthetics and other drugs, and to speed recovery time. A reduction in intensive care and total hospital stay should result, leading to an increase quality of life following the procedure and a reduction in cost.
The primary objective of this investigational plan is to determine the safety of the Valiant endoluminal device when used to exclude thoracic lesions: true descending thoracic aortic aneurysms, dissections, penetrating ulcers, traumatic transections and traumatic and degenerative pseudoaneurysms from blood flow in high risk and low risk patients who are candidates for endoluminal repair.
Patients should be heparinized during the implant procedure (recommended activated clotting time is 200-300 seconds). During implantation of the Valiant endoluminal stent-graft, the pre-implant angiogram and CT scan are used together with (on-the-table) intravascular ultrasound (IVUS), digital subtraction angiography (DAS), roadmapping, and angiography for proper implant positioning. The Valiant endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The introducer sheath and delivery catheter containing the stent-graft is inserted over a guidewire and advanced into the aorta and above the aneurysm. With the delivery catheter in the correct position, the introducer sheath is then withdrawn further until the stent-graft is completely deployed. A separate stent-graft balloon catheter system is provided with the device and may be used along the full length of the implanted device to model the springs against the vessel wall and to unravel possible wrinkles in the graft fabric. After deployment of the stent-graft, angiography is performed to verify implant position and to check for the presence of endoleaks.
Subjects will undergo an evaluation of the Valiant endoluminal stent-graft to determine the safety and efficacy of the device as indicated by the adverse event rate, and to determine the risk factors that are most predictive of a successful outcome when used to exclude thoracic aortic aneurysms that require suprarenal fixation in high risk and low risk patients. Follow-up will be completed at 1, 6, 12, 24, 36, 48, and 60 months. Subject evaluation at 1 month will include a Complete Physical Exam, Labs (BUN and Creatinine), and a Thoracic Spiral CT with and without IV contrast 2.5 mm. Subject evaluation at 6, 12, 24, 36, 48, and 60 months will include a Complete Physical Exam, Chest X-ray (AP, Lateral), Labs (BUN and Creatinine), and a Thoracic Spiral CT with and without IV contrast 2.5 mm.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter
VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter
VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
* Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging \[ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography\].
* A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer;
* Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; or
* Penetrating aortic ulcer in the absence of an aneurysm; or
* Traumatic transection; or
* Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin.
* Subject's anatomy is suitable for placement of the TALENT endoluminal stent-graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
* Subject has a TAA that is dilated to ≥ 5 cm in diameter, ≥ 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
* Subject has a proximal and distal aortic neck diameter ≥ 18 mm and ≤ 42 mm.
* Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
* Subject has signed the informed consent.
* Subject will be available for the periodic follow-up (surveillance) after the procedure.
* Aortic.
Exclusion Criteria
* Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
* Subject has a lesion that prevents delivery or expansion of the device.
* Subject has systemic infection, or is suspected of having systemic infection.
* Subject has a known mycotic aneurysm.
* Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arizona Heart Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arizona Heart Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward B Diethrich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Arizona Heart Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Heart Institute
Phoenix, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Coselli JS, S Buket, and ES Crawford. 1996. Thoracic aortic aneurysms. In: Haimovicis Vascular Surgery, 4th ed, H Haimovici, E Ascer, LH Hollier, DE Strandness, and JB Towne, eds. Blackwell Science, chapter 57.
Coselli JS and SA LeMaire. 1995. Diseases of the thoracic aorta. In: Current Diagnosis and Treatment in Vascular Surgery, 1st ed, RH Dean, JST Yao, and DC Brewster, eds. Appleton & Lange, Norwalk, CT, chapter 11.
Dake MD, Miller DC, Semba CP, Mitchell RS, Walker PJ, Liddell RP. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med. 1994 Dec 29;331(26):1729-34. doi: 10.1056/NEJM199412293312601.
Mitchell RS, Miller DC, Dake MD. Stent-graft repair of thoracic aortic aneurysms. Semin Vasc Surg. 1997 Dec;10(4):257-71.
Moreno-Cabral CE, Miller DC, Mitchell RS, Stinson EB, Oyer PE, Jamieson SW, Shumway NE. Degenerative and atherosclerotic aneurysms of the thoracic aorta. Determinants of early and late surgical outcome. J Thorac Cardiovasc Surg. 1984 Dec;88(6):1020-32.
Najafi H. Thoracic aortic aneurysm: evaluation and surgical management. Compr Ther. 1994;20(5):282-8. No abstract available.
Pressler V, McNamara JJ. Thoracic aortic aneurysm: natural history and treatment. J Thorac Cardiovasc Surg. 1980 Apr;79(4):489-98. No abstract available.
Skeens JL and MD Dake. 1997. Thoracic aortic aneurysm stent-grafts. Eighth Complex Peripheral Angioplasty Course. Paris, May 20-23, 1997, pp. 289-295.
Nienaber CA, Fattori R, Lund G, Dieckmann C, Wolf W, von Kodolitsch Y, Nicolas V, Pierangeli A. Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement. N Engl J Med. 1999 May 20;340(20):1539-45. doi: 10.1056/NEJM199905203402003.
White RA, Donayre CE, Walot I, Lippmann M, Woody J, Lee J, Kim N, Kopchok GE, Fogarty TJ. Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device. J Vasc Surg. 2001 May;33(5):927-34. doi: 10.1067/mva.2001.114998.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G020150
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.