Clinical trials: Claudication
Peripheral Arterial Disease, Intermittent Claudication
Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System
An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Trial name
- SPRINT (NCT02097082)
- Testing
- STANZA Drug-eluting resorbable Scaffold
- Where
- 9 sites in Austria, Germany and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- 480 Biomedical
Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Trial name
- STANCE (NCT01403077)
- Testing
- 480 Biomedical Bioresorbable Scaffold System
- Where
- 6 sites in Australia, Austria and 2 more
- Volunteers
- 46 people
- Sponsor
- 480 Biomedical
Intermittent Claudication
A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).
- Trial name
- NCT00403494
- Testing
- Sapropterin Dihydrochloride
- Where
- 20 sites in United States, Argentina
- Volunteers
- 190 people
- Sponsor
- BioMarin Pharmaceutical
Lumbar Spinal Stenosis
Condition of Approval Study
This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population…
- Trial name
- COAST (NCT00517751)
- Testing
- X-STOP PEEK
- Where
- 23 sites in United States
- Volunteers
- 176 people
- Sponsor
- Medtronic Spine LLC
Peripheral Arterial Disease
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
- Trial name
- VBXFLEX (NCT02080871)
- Testing
- Stenting of the Common and/or External Iliac Arteries
- Where
- 27 sites in United States, New Zealand
- Volunteers
- 134 people
- Sponsor
- W.L.Gore & Associates
Intermittent Claudication
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated…
- Trial name
- NCT06886620
- Testing
- Cilostazol 200 mg, Cilostazol 100 mg
- Where
- 5 sites in Taiwan
- Volunteers
- 14 people
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1
Pedicle Osteotomy for Stenosis Trial
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1, Neurogenic Claudication
- Trial name
- POST (NCT03381677)
- Testing
- Pedicle Lengthening Osteotomy with Altum® Device, Control
- Where
- United States
- Volunteers
- 344 people
- Sponsor
- Innovative Surgical Designs
Spinal Stenosis
Intermittent Neurogenic Claudication Treatment With APERIUS®
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius®…
- Trial name
- INCA (NCT00887744)
- Testing
- Aperius® Percutaneous Interspinous Spacer
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 162 people
- Sponsor
- Medtronic Spinal and Biologics
Peripheral Vascular Disease
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg…
- Trial name
- NCT00113009
- Testing
- VLTS-934
- Where
- 32 sites in United States
- Volunteers
- 148 people
- Sponsor
- Valentis
Neurologic Claudication in Patients With Lumbar Spinal Stenosis
A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis
This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic…
- Trial name
- NCT01888536
- Testing
- Limaprost, Pregabalin
- Where
- 7 sites in South Korea
- Volunteers
- 182 people
- Sponsor
- Yungjin Pharm. Co., Ltd.
Intermittent Claudication
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of…
- Trial name
- NCT06167265
- Testing
- Cilostazol Tablet 100 mg, PMR Tablet 145 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Peripheral Arterial Disease, Intermittent Claudication
Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System
The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD).
- Trial name
- REALITY III (NCT03071146)
- Testing
- Bard® LifeStent® 5F Vascular Stent System
- Where
- 4 sites in Germany
- Volunteers
- 30 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease, Peripheral Vascular Disease
Absolute Pro® MOMENTUM™
To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or…
- Trial name
- MOMENTUM (NCT01444378)
- Testing
- Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Abbott Medical Devices
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MiDAS ENCORE Study
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having…
- Trial name
- NCT02093520
- Testing
- MILD Procedure, Epidural Steroid Injection
- Where
- 12 sites in United States
- Volunteers
- 302 people
- Sponsor
- Vertos Medical, Inc.
Intermittent Claudication, Peripheral Vascular Disease
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.
- Trial name
- NCT00071266
- Testing
- Niacin Extended Release and Lovastatin Tablets
- Where
- 26 sites in United States
- Volunteers
- 870 people
- Sponsor
- Kos Pharmaceuticals
Iliac Artery Stenosis
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
- Trial name
- ORION (NCT00896337)
- Testing
- Epic™ Nitinol Stent System, Anti-platelet therapy, Anti-coagulation therapy
- Where
- 28 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Scientific Corporation
Peripheral Vascular Disease, Intermittent Claudication
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market.
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty, Critical Limb Ischemia
- Trial name
- FlowOx (NCT04100681)
- Testing
- Active FlowOx™
- Where
- 5 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Otivio AS
Peripheral Arterial Disease, Claudication
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT02475200
- Testing
- Atherectomy
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Peripheral Vascular Disease
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
- Trial name
- MOBILITY AP (NCT00844532)
- Testing
- Absolute Pro™ Peripheral Self-Expanding Stent System
- Where
- United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
Intermittent Claudication, Atherosclerotic Disease
Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral…
- Conditions
- Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease
- Trial name
- RESILIENT (NCT00673985)
- Testing
- Percutaneous Transluminal Angioplasty, LifeStent NT™ Self-Expanding Peripheral Stent
- Volunteers
- 246 people
- Sponsor
- C. R. Bard