Clinical trials: Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
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.
- Trial name
- CHAMPIONSHIP (NCT06410313)
- Testing
- ChampioNIR Ridaforolimus Eluting Peripheral Stent System
- Where
- 7 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
Popliteal Stenosis, Popliteal Artery Occlusion
DCB Compared Stenting in Popliteal Lesions
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
- Conditions
- Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes
- Trial name
- NCT03739580
- Testing
- DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.), Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Arterial Disease
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty
The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery…
- Trial name
- NCT04238546
- Testing
- sirolimus-coated balloon catheter, uncoated balloon catheter
- Where
- 2 sites in Switzerland
- Volunteers
- 1,200 people
- Sponsor
- Nils Kucher
Atherosclerosis
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral…
- Trial name
- NCT03455855
- Testing
- Jetstream System
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Boston Scientific Corporation
Popliteal Artery Disease
Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
Prospective, multi-center, single-arm registry study A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled.
- Trial name
- NCT02698345
- Testing
- drug-eluting balloon (In.PACT Admiral, Medtronic)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Peripheral Arterial Disease
In.Pact Flexion, Investigating the Performance of the In.Pact Admiral DEB for Popliteal Lesions
The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions
- Trial name
- INPCTFLEXION (NCT02678065)
- Testing
- InPact Admiral DEB
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program
Atherosclerosis, Ischemia
Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
- Trial name
- NCT02840786
- Testing
- plaque excision system, balloon and Stent
- Where
- China
- Volunteers
- 221 people
- Sponsor
- Xuanwu Hospital, Beijing
Atherosclerosis
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal…
- Trial name
- NCT02118532
- Testing
- IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Where
- 15 sites in China
- Volunteers
- 143 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
- Trial name
- PRELUDE (NCT03001700)
- Testing
- Serranator™ Alto PTA Serration Balloon Catheter
- Where
- 4 sites in Austria, New Zealand and 1 more
- Volunteers
- 25 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease
Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)
To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral…
- Trial name
- JETART (NCT06434779)
- Testing
- JETi 6F and 8F Thrombectomy system
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Vascular Science LP GmbH
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
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.™…
- Conditions
- Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- REAL-SMART (NCT07338890)
- Testing
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Cordis US Corp.
Peripheral Artery Disease, Popliteal Aneurysm
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms
- Trial name
- NCT04907240
- Testing
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Where
- 26 sites in Belgium, France and 7 more
- Volunteers
- 614 people
- Sponsor
- W.L.Gore & Associates
Critical Limb Ischemia
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as…
- Trial name
- NCT00651885
- Testing
- treprostinil dienthanolmine sustained release
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ochsner Health System
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases
- Trial name
- LEGDEB2 (NCT04175197)
- Testing
- Drug Coated Balloon
- Where
- 7 sites in Italy, Mexico
- Volunteers
- 512 people
- Sponsor
- Federico II University
Peripheral Arterial Disease
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an…
- Trial name
- DANCE (NCT01507558)
- Testing
- Administration of dexamethasone to SFA/popliteal adventitia
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of California, San Francisco
Peripheral Vascular Diseases
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease…
- Trial name
- Remove (NCT04986098)
- Testing
- TurboHawk, Paclitaxel
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Soochow University
Peripheral Arterial Disease
Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA…
- Trial name
- PACUBA 1 (NCT01247402)
- Testing
- drug eluting balloon angioplasty, standard balloon angioplasty
- Where
- 2 sites in Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
Critical Limb Ischemia
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.
- Trial name
- NCT02498080
- Testing
- DEB PTA, Standard PTA
- Volunteers
- 60 people
- Sponsor
- Neuromed IRCCS