NCT02734836

Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)

Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Arkansas Heart Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Balloon Angioplasty
OTHER	Optical Coherence Tomography

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-10-02
• Completion: 2018-10-02
• First posted: 2016-04-12
• Last updated: 2019-06-26

Locations

1 site across 1 country: United States