Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Arkansas Heart Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Optimal Coherence Tomograpy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant stenosis).
Detailed Description
Endovascular therapy is widely used for the treatment of peripheral artery disease (PAD). Primary nitinol stenting for superficial femoral artery (SFA)) lesions has been shown to be superior to balloon angioplasty alone. Zilver PTX a paclitaxel -eluting nitinol stent has been approved by the Food and Drug Administration (FDA) for femoro-popliteal artery use. Previous study have reported safety and effectiveness of the Zilver PTZ in patients with de novo or re-stenotic lesions of the femoro-popliteal artery. Optical Coherence tomography (OCT) is a novel intravascular imaging modality with a unique and fine resolution of 10 µm at the level of a red blood cells providing detailed images of vascular wall following stent implantation for evaluation of optimal stent apposition and expansion as well as intraluminal clot. 20 patients with symptomatic critical limb ischemia (CLI) and claudication without CLI (Rutherford class 2-6) and identifiable SFA disease on angiogram requiring percutaneous peripheral intervention (PPI)will be enrolled in this study. We would like to study the vessel apposition and expansion immediately after initial implantation as well as evaluation of late stent malapposition and neointimal hyperplasia at the 12 months follow up after Zilver PTXTM stent implantation using intravascular OCT imaging. Follow up visits will take place at 1 month, 6 month, 12 month and 13 month after the procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with lower extremity claudication and Peripheral Arterial Disease (PAD) due to significant SFA stenosis (60%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.
- •Evidence of significant SFA disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following:
- •ABI: \<0.9 (If ABI\>1.4, SFA systolic acceleration time should be \> 140 milliseconds);
- •TBI: \<0.6;
- •Computed Tomographic Angiography (CTA) confirming at least a 60% SFA stenosis; or
- •Magnetic Resonance Angiography (MRA) confirming at least a 60% SFA stenosis
- •At least one patent, non-treated below the knee vessel.
- •Male and female patients that are ≥ 18 years of age.
- •Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
- •Peak Walking Time (PWT) limited only by claudication.
Exclusion Criteria
- •Planned usage of atherectomy devices during procedure. The following devices are the only permitted devices that can be used for intervention procedures:
- •Conventional balloons
- •Zilver PTXTM stent
- •Planned amputation.
- •Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure.
- •Prior lower extremity revascularization ≤ 30 days before baseline procedure.
- •The target lesion is an in-stent restenosis.
- •Infra-popliteal disease involving the last remaining vessel.
- •Patients with a creatinine clearance \< 30mL/min.
- •Patients with known bleeding disorders.
Outcomes
Primary Outcomes
Optimal Coherence Tomograpy
Time Frame: 12 Month
Identification of optimal stent apposition and expansion as well as identification of intraluminal clot at 12 month post procedure.