Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease, Dissection Arterial
Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial.
Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease and have negative impact upon the outcomes of the treatment. Objective.
- Trial name
- LOVES (NCT04442802)
- Testing
- Percutaneous transluminal angioplasty
- Where
- Moldova
- Volunteers
- 100 people
- Sponsor
- Dumitru Casian
Peripheral Arterial Disease, Atherosclerosis
Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal…
- Trial name
- SCENARIO-FP (NCT02544555)
- Testing
- Intentional intraluminal approach, Intentional subintimal approach
- Where
- 3 sites in South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Korea University Guro Hospital
Peripheral Arterial Disease
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease.
- Trial name
- STRIKE (NCT06636968)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
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.
Peripheral Vascular Disease
Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)
The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pulsar-18 stent implantation in…
- Trial name
- BIOLUX 4EVER (NCT02211664)
- Testing
- Passeo-18 balloon, Passeo-18 Lux drug releasing balloon, Pulsar-18 stent
- Where
- 5 sites in Belgium
- Volunteers
- 120 people
- Sponsor
- Flanders Medical Research Program
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 Occlusive Disease
The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
- Trial name
- NCT04698304
- Testing
- endovascular treatment
- Where
- China
- Volunteers
- 1,518 people
- Sponsor
- RenJi Hospital
Peripheral Arterial Disease
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
- Trial name
- NCT05894863
- Testing
- Smart flex stent
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RenJi Hospital
Peripheral Artery Disease, In-stent Restenosis
LDD in Treatment of Femoropopliteal ISR
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis.
- Trial name
- NCT03521843
- Testing
- balloon dilation only, balloon dilation+local drug delivery
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RenJi Hospital
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
Cardiovascular Diseases
SuperB Trial: SUrgical Versus PERcutaneous Bypass
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency.
- Trial name
- SuperB (NCT01220245)
- Testing
- Heparin-bonded ePTFE endoluminal fem-pop bypass, Surgical femoro-popliteal bypass.
- Where
- 6 sites in Netherlands
- Volunteers
- 129 people
- Sponsor
- Rijnstate Hospital
Femoropopliteal Occlusive Disease
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
- Trial name
- NCT05082532
- Testing
- Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Peripheral Artery Disease
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system（G-stream） in the treatment of femoropopliteal artery stenosis or occlusion.
- Trial name
- G-streamPAD (NCT05780359)
- Testing
- Drug eluting stent, drug coating balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Atherosclerosis, Lower Extremity Ischemia
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs.
- Conditions
- Atherosclerosis, Lower Extremity Ischemia, Claudication, Rest Pain
- Trial name
- NCT00962897
- Testing
- Femoral-popliteal bypass, Stent-graft placement
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Texas Vascular Associates
Femoral Artery Stenosis, Angioplasty
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries.
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular
- Trial name
- DkuLL CALVEP (NCT07397390)
- Testing
- DKutting LL scoring balloon angioplasty
- Where
- China
- Volunteers
- 58 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Peripheral Arterial Disease, Claudication
Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient
1. To perform an observational analysis to determine if mean translesional gradient measurements (TLG) are associated with differences in clinical outcomes in patients with femoropopliteal arterial disease and claudication. 2.
- Trial name
- NCT02387658
- Testing
- translesional gradient measurement
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- North Texas Veterans Healthcare System
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-eluting balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
Peripheral Artery Disease
Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with…
- Trial name
- SIRONA (NCT04475783)
- Testing
- Percutaneous Transluminal Angioplasty (PTA)
- Where
- 22 sites in Austria, Germany
- Volunteers
- 478 people
- Sponsor
- Jena University Hospital
Femoropopliteal Lesion
DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions
Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months.
- Trial name
- REBOOST (NCT06835660)
- Testing
- procedure of DCB implantation, procedure of SEDES implantation
- Where
- France
- Volunteers
- 402 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Peripheral Arterial Disease, Peripheral Artery Disease
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
- Trial name
- PREVISION (NCT05556681)
- Testing
- BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
- Where
- 10 sites in Australia, New Zealand and 1 more
- Volunteers
- 34 people
- Sponsor
- C. R. Bard