A. Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence (CHOICE)
PI: Paul Armstrong, D.O.
Summary: A prospective, non-randomized, multi-center, descriptive, post-market study of two carotid artery stent systems and two embolic protection systems.
Inclusion:
· Patient or patient's legally authorized representative provided informed consent.
· Patient is considered at high risk for carotid endarterectomy (CEA).
· Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
· Patient's physician intends to use an RX Acculink with the RX Accunet in the carotid artery or an Xact with the emboshield in the carotid artery as per FDA approved indication for use.
Exclusion:
· There are no exclusion criteria for this study
B. Evaluation of the GORE Conformable TAG Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection (TAG 08-01)
PI: Martin Back, M.D.
Summary: A prospective, non-randomized, multi-center study to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endorposthesis for treatment of acute complicated type B aortic dissection.
Test Group: Subjects prospectively treated with the GORE Conformable TAG Thoracic Endoprosthesis for acute complicated type B aortic dissection.
Inclusion:
· Presence of acute complicated type B aortic dissection
· Dissection is complicated
· Dissection is type B
· Primary treatment indication is class 1 aortic dissection
Exclusion:
· Primary treatment indication is class 2-5 aortic dissection
· Prior repair of DTA
· Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair
· Subject has a systemic infection and may be at risk for endovascular graft infection.
· Persistent refractory shock
· Bowel necrosis
· Renal failure
· ASA risk classification=V
· Pregnant female
· Major surgery within 30 days of treatment
· Degenerative connective tissue disease
· Enrollment in another study within 1 year of study enrollment
· History of stimulant abuse
C. Evaluation of the GORE Conformable TAG Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta (GORE 08-02).
PI: Murray Shames, M.D.
Inclusion:
· Traumatic Transection of the DTA that requires repair, determined by the treating physician
· Traumatic aortic transaction location between, but does not include, the left subclavian artery and celiac artery
· Endovascular repair with the conformable GORE TAG device performed <14 days after aortic injury
· Age > 18 years
· Proximal and distal landing zone length > 2.0 cm
· All proximal and distal landing zone inner diameters are between 16-42 mm
· Subject capable of complying with study protocol requirements, including follow-up
· Informed consent form signed by subject or legal representative
Exclusion:
· Differing proximal and distal neck diameters outside the intended oartic diameter requirements for single endoprosthesis diameter and the inability to use devices of different diameters to compensate for the taper
· Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access.
· Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zones
· Infected aorta
· Subject has a systemic infection and may be at increased risk of endovascular graft infection
· Planned coverage of left carotid or celiac arteries with the CTAG Device
· Known degenerative connective tissue disease
· Treatment in another drug or medical device study within 1 year of study
· Known history of drug abuse
· Pregnant female
· Injury Severity Score of 75
· Moribund patient not expected to live 24 hours with/without operation
· Subject has known sensitivities or allergies to the device materials
D. Zenith TX2 TAA Endovascular Graft Post-Approval Study
PI: Martin Back, M.D.
Summary: This is a post-approval study to evaluate the long-term safety and performance of the Zenith TX2 TAA Endovascular Graft in the elective treatment of patients with descending thoracic aortic aneurysms or ulcers.
Inclusion:
· Descending thoracic aneurysm with diameter of >5.0 cm
· Descending thoracic aneurysm with a history of growth > 0.5 cm in 12 months
· Descending thoracic degenerative or atherosclerotic ulcers>10 mm in depth and 20 mm in diameter
Exclusion:
· Age <18
· Other medical condition that may cause the patient to be non-compliant with the protocol
· Pregnant
· Unwilling or unable to comply with the follow-up schedule
· Inability or refusal to give informed consent
· Simultaneously participating in another investigative device or drug study
E. TALENT CONVERTER POST-APPROVAL STUDY
Device: Talent Converter Stent Graft with Xcelerant Hydro Delivery System
PI: Murray Shames
Summary:
The purpose of this trial is to evaluate physician experience and device performance of the Talent Converter Stent Graft and the Talent Occluder device in a post-approval environment.
Inclusion:
· Subjects in whom a vessel access procedure was/will be performed with the attempted introduction of the Talent Converter Stent Graft according to the indications for use
· Subjects who are able to understand the nature of the study and give voluntary informed consent
· Subjects who are available for follow-up visits
· Subjects 18 years or age or older
Exclusion:
· Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft other than as a secondary endovascular intervention for patients having received prior endovascular repair with either a Talent AneuRx bifurcated stent graft.
· Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft as a secondary endovascular intervention for patients having received prior endovascular repair with bifurcated stent graft other than a Talent or AneuRx bifurcated stent graft.
F. FINEST Study- Comparison of Safety and Primary Patency Between FUSION Vascular Graft, FUSION Vascular Graft with BiolineE, and EXXCEL Soft ePTFE
PI: Dennis Bandyk, M.D.
Summary: A randomized multicenter study evaluating the FUSION Vascular Graft, FUSION Vascular Graft with BiolinE and the EXXCEL Soft ePTFE for above-knee femoropopliteal bypass grafting.
Please contact me for a complete list of inclusion/exclusion criteria
Thank you for taking the time to look over our current trials. Please do not hesitate to contact me any time if you have questions (813) 600-9674
Thank you,
Stephenie Yapchanyk, RN
Research Coordinator/Vascular Surgery
syapchan@health.usf.edu
