Clinical Research Directory

SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.

SELUTION4SFA Trial

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease

This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound

The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)

The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.

STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions

The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and/or popliteal arteries (SFA/PA) of patients with symptomatic peripheral artery disease (PAD). The study enrolls patients who have been diagnosed with peripheral artery disease with stenosis of the superficial femoral or popliteal artery and are qualified for endovascular revascularization. Lower extremity peripheral artery disease may be asymptomatic or may be accompanied by clinical symptoms due to restricted blood flow to the lower extremities. The management of a patient diagnosed with peripheral arteriosclerosis is primarily aimed at reducing symptoms of limb ischemia and improving blood supply to the limb, as well as seeking to halt the progression of the disease. Treatment of lower extremity atherosclerosis with percutaneous methods is a well-known minimally invasive and recommended treatment for lower extremity ischemia. A maximum of 120 patients will be included in the study. All patients included in the study will receive treatment with the investigational device. The study will use the PAK balloon catheter, which is CE certified and approved for the treatment of patients with peripheral vascular disease. That is, it is also used as standard outside the study. The test procedure with the study device is in accordance with its registration and instructions for use.