None listed
Conditions
Brief summary
The newer generation TIGRIS GORE nitinol stent observed in this study has been used successfully in many practices in Australia. Given the clinical equipoise surrounding the optimal choice of stent in the treatment of femoropopliteal artery disease, it is routine practice for some surgeons and centres to choose to use this stent for their patients. This study will act as a registry for patients who receive a GORE TIGRIS stent in treatment of their peripheral artery disease, and serve to provide further data for use of this stent in a real-world setting.
Interventions
The GORE TIGRIS stent has had promising results in terms of previous literature.
Patients who receive the GORE TIGRIS stent as part of their routine clinical care at the discretion of their treating vascular surgeons will be identified post operatively by study personnel. At this stage, they will be approached by one of the researchers, at a suitable time point during their routine hospital attendance, and at such time will be invited to participate in the trial. Patient information sheets and
The GORE TIGRIS stent has had promising results in terms of previous literature. Patients who receive the GORE TIGRIS stent as part of their routine clinical care at the discretion of their treating vascular surgeons will be identified post operatively by study personnel. At this stage, they will be approached by one of the researchers, at a suitable time point during their routine hospital attendance, and at such time will be invited to participate in the trial. Patient information sheets and consent forms will be provided to potential prospective patients for review, and following all responses to questions and if they wish to participate, written informed consent will be obtained and the patient will be enrolled into the study. Patients who have received treatment of their femoro-popliteal arterial disease with this stent attend routine outpatient clinic visits at 3, 6, 12, 24 and 36 months. At each follow-up clinic patients will undergo routine assessment, which will include clinical assessment of symptomatology and duplex ultrasound for evidence of stent patency, occlusion or fracture. Any surgical re-interventions undertaken to the area treated with the GORE TIGRIS stent will be recorded. This information will be collected on all enrolled patients to a minimum of 12 months, with an aim to continue data collection on all patients out to 3 years.
Sponsors
Dr. Vikram Puttaswamy (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or above Patients with arterial disease from the SFA origin to the popliteal bifurcation scheduled to be treated or have been treated with the TIGRIS GORE stent De novo lesions and post-angioplasty stenoses All lesion lengths suitable for a TIGRIS GORE stent
Exclusion criteria
Lesions with in-stent restenosis Patients contraindicated to having dual antiplatelet or anticoagulation therapy including a history of heparin induced thrombocytopenia and thrombosis (HITTS)
Outcome results
None listed