Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
Femoropopliteal Occlusive Disease
Accessing Peripheral Occluded LesiOns II (APOLO-II)
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for…
- Trial name
- APOLO-II (NCT01884701)
- Testing
- ENABLER-P Catheter System
- Sponsor
- EndoCross Ltd.
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
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)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 34 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Vascular Disease, Peripheral Arterial Disease
EVERO Drug-coated Balloon (DCB) Randomized Trial
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero…
- Trial name
- NCT07144150
- Testing
- Evero DCB, Paclitaxel DCB
- Where
- 15 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
Peripheral Arterial Disease
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or…
- Trial name
- NCT02469532
- Testing
- Balloon Angioplasty, Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Arterial Disease, Calcifications Vascular
SOLUTION Trial in China
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
- Trial name
- NCT05434676
- Testing
- Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
- Where
- 5 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease (PAD)
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Femoropopliteal Occlusive Disease, Below-the-knee Obstruction
- Trial name
- NCT03414515
- Testing
- Endovascular intervention
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed
Peripheral Artery Disease
Zilver® PTX® in China
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
- Trial name
- NCT02171962
- Testing
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Where
- 9 sites in China
- Volunteers
- 178 people
- Sponsor
- Cook Group Incorporated
Thrombosis, Deep Vein, Iliofemoral; Thrombosis
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate…
- Trial name
- DEXTERITY-AFP (NCT04862468)
- Testing
- Perivascular dexamethasone
- Where
- 22 sites in United States, Ireland and 1 more
- Volunteers
- 80 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Arterial Disease (PAD)
Zilver PTX Post-Market Study in Japan
Japanese post market clinical study of the Zilver PTX device.
- Trial name
- NCT02254837
- Testing
- Zilver PTX Drug-Eluting Stent
- Volunteers
- 909 people
- Sponsor
- Cook Group Incorporated
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
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.
- Trial name
- NCT01628159
- Testing
- Lutonix Drug Coated Balloon
- Where
- 64 sites in United States, Austria and 3 more
- Volunteers
- 657 people
- Sponsor
- C. R. Bard
Atherosclerosis, Vascular Disease
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
- Conditions
- Atherosclerosis, Vascular Disease, Arteriosclerosis
- Trial name
- LEVANT I (NCT00930813)
- Testing
- Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 101 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
- Trial name
- NCT04982367
- Testing
- Sirolimus-eluting balloon catheter, Paclitaxel-eluting balloon catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018)…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Below-the-knee Obstruction, Femoropopliteal Occlusive Disease
- Trial name
- PAD (NCT03346577)
- Testing
- stent or balloon
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- be Medical
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- Trial name
- NCT07425171
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation
Peripheral Vascular Disease, Femoral Occlusive Disease
New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results.
- Conditions
- Peripheral Vascular Disease, Femoral Occlusive Disease, Femoropopliteal Occlusive Disease, Aortoiliac Atherosclerosis
- Trial name
- VJ (NCT01514916)
- Testing
- mechanical anastomosis without suture
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Ab Medica Spa
Peripheral Artery Disease, Femoropopliteal Artery Disease
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.
- Trial name
- PAX (NCT02145065)
- Testing
- Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland), Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
- Where
- Poland
- Volunteers
- 66 people
- Sponsor
- Balton Sp.zo.o.
Femoropopliteal Occlusive Disease, Peripheral Artery Disease
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
- Trial name
- KANSHAS-1 (NCT02939924)
- Testing
- Kanshas DCB
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Terumo Europe N.V.