Clinical trials: Restenosis of Peripheral Vascular Stent
Restenosis, Peripheral Vascular Disease
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone.
- Trial name
- JetStreamISR (NCT01722877)
- Testing
- JetStream Navitus
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Restenosis, Peripheral Arterial Disease
Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
- Trial name
- PacTAP (NCT01599078)
- Testing
- Paclitaxel
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Midwest Cardiovascular Research Foundation
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
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for…
- Trial name
- TRIUMPH (NCT01099215)
- Testing
- PVS-10200
- Where
- 3 sites in France
- Volunteers
- 21 people
- Sponsor
- Shire
Peripheral Arterial Disease
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
- Trial name
- INSIGHT (NCT03192696)
- Testing
- Atherectomy Catheter
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Avinger, Inc.
Peripheral Arterial Disease, Femoropopliteal Lesions
BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably…
- Trial name
- BATTLE (NCT02004951)
- Testing
- Misago RX, Zilver PTX
- Where
- 11 sites in France
- Volunteers
- 186 people
- Sponsor
- Nantes University Hospital
Peripheral Vascular Disease
Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery
The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral…
- Trial name
- ISAR-PEBIS (NCT01083394)
- Testing
- PTA, PTA with PEB, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 2 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Peripheral Arterial Disease
Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis
Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even…
- Trial name
- NCT04123639
- Testing
- PTA
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Assiut University
Peripheral Arterial Disease
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.
- Trial name
- NCT02499510
- Testing
- GoldenFlow Stent
- Where
- Hong Kong
- Volunteers
- 5 people
- Sponsor
- Chinese University of Hong Kong
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
Iliac Artery Disease
Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)
Prospective, single-arm, multi-center registry study A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included.
- Trial name
- NCT02698358
- Testing
- Epic stent (Boston Scientific)
- Where
- South Korea
- Volunteers
- 68 people
- Sponsor
- Yonsei University
Peripheral Vascular Diseases
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
- Trial name
- NCT00180505
- Testing
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Where
- 13 sites in Austria, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Catherization
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries
In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
- Trial name
- NCT01594684
- Testing
- balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.), drug coated balloon inflation (Cotavance, Medrad Inc.), uncoated balloon (e.g. Admiral, Medtronic)
- Where
- 6 sites in Germany
- Volunteers
- 112 people
- Sponsor
- Prof. Dr. med. Gunnar Tepe
Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent
Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease
The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF)…
- Conditions
- Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent, Restenosis, Vascular Graft, Endothelial Dysfunction
- Trial name
- NCT04391374
- Testing
- an arterial reconstructive procedure
- Volunteers
- 167 people
- Sponsor
- Ryazan State Medical University
PERIPHERAL VASCULAR DISEASE
Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent restenosis) due to in growth of…
- Trial name
- COBRA (NCT00827853)
- Testing
- Conventional angioplasty balloon, cryoplasty balloon
- Where
- 4 sites in United States
- Volunteers
- 90 people
- Sponsor
- North Texas Veterans Healthcare System
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- K-ELUVIA (NCT06234280)
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Peripheral Artery Disease, Vascular Disease
In-Stent Restenosis Post-Approval Study
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
- Trial name
- NCT02542267
- Testing
- Gore VIABAHN Endoprosthesis
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 108 people
- Sponsor
- W.L.Gore & Associates
Femoropopliteal Artery Disease
Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
Prospective, single-arm, multi-center registry study A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Trial name
- NCT02701816
- Testing
- innova stent (Boston scientific)
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Yonsei University
Peripheral Vascular Disease
GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis
This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L.
- Trial name
- RELINE (NCT01108861)
- Testing
- GORE VIABAHN® Endoprosthesis, Plain old balloon angioplasty
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program