Clinical Trials About "Vascular Begins Enrollment Pivotal Study Drug Coated Peripheral" RSS

01:19 EST 24th February 2018 | BioPortfolio

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Showing "Vascular Begins Enrollment Pivotal Study Drug Coated Peripheral" Clinical Trials 1–25 of 10,000+

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ILLUMENATE Pivotal Post-Approval Study (PAS)

The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

LEVANT 2 Safety Registry

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.


Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions. The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently ...

Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is batter in effectiveness and clinical performance compared with similar products already on the market.

Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - DCB

Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.

Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions

The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended. The primary objective of this study is to compare the performance of drug-coated balloon angiopla...

ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. O...

Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.

CVI Drug Coated Balloon First In Human Trial

The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries. The primary endpoint for this analysis is late lumen loss at six (6) months.

Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis

The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard...

Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.

Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft

To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency.

Stellarex Vascular E-Registry

Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries. The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.

Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be...

Athrectomy and Drug Eluting Balloon Therapy (ADEBT) on the Femoral Popliteal Arteries

The aim of this study is to study the effects of athrectomy followed by percutaneous transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic peripheral vascular disease in an Asian population. We intend to study the effects of debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in improved patency rates The study will pros...

AcoArt III / AVF China

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug...

First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

The All-comers Sirolimus-coated Balloon European Registry

The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting Drug Coated Balloon for the treatment of any type of coronary lesions, including native vessel disease and in stent restenosis.

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