Clinical trials: Atherosclerosis
Aortoiliac Occlusive Disease, Peripheral Arterial Disease
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
- Trial name
- NCT05811364
- Testing
- Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 244 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
BIOLUX P-III BENELUX All-Comers Registry
The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated…
- Trial name
- NCT03052309
- Testing
- Passeo-18 Lux DCB
- Where
- 9 sites in Belgium, Luxembourg and 1 more
- Volunteers
- 106 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease, Peripheral Vascular Diseases
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
- Trial name
- NCT03193619
- Testing
- PTA (UltraScore Focused Force PTA Balloon)
- Where
- 31 sites in United States
- Volunteers
- 350 people
- Sponsor
- C. R. Bard
Diabetic Foot, Peripheral Arterial Disease
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD).
- Trial name
- NCT02460081
- Testing
- PDA-002
- Where
- United States
- Sponsor
- Celularity Incorporated
Peripheral Arterial Disease
Clinical Testing Study in Peripheral Arterial Disease
The Purpose of the Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD) study is to compare measurement outcomes between conventional Ankle-Brachial Index test for Peripheral Arterial Disease with a new imaging…
- Trial name
- CTS-PAD (NCT05243992)
- Testing
- CTS-PAD device imaging
- Volunteers
- 50 people
- Sponsor
- Perfusio Corp.
Coronary Artery Disease, Peripheral Arterial Disease
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Trial name
- NCT05747287
- Testing
- microcatheter
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- BrosMed Medical Co., Ltd
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
Peripheral Arterial Disease
"Unifuzol®" in Patients With Peripheral Arterial Disease
The present study is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of the drug Unifuzol® (L-arginine) in patients with obliterating atherosclerosis of the lower extremities.
- Trial name
- NCT03861416
- Testing
- L-arginine 1.4% 500 ml
- Where
- 19 sites in Russia
- Volunteers
- 360 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Atherosclerotic Cardiovascular Disease
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
This study will evaluate cardiovascular outcomes among individuals with clinically established atherosclerotic cardiovascular disease (ASCVD) who have not previously experienced a myocardial infarction (MI) or ischemic stroke.
- Trial name
- NCT07905534
- Where
- Spain
- Volunteers
- 18,000 people
- Sponsor
- Sanofi
Peripheral Arterial Diseases
PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses
The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to…
- Trial name
- NCT02786043
- Testing
- Propionyl-L-Carnitine Hydrochloride
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Peripheral Arterial Disease
Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC
Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound healing and prevent tissue necrosis in animals.
- Trial name
- NCT01401517
- Testing
- sodium nitrite
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- TheraVasc Inc.
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
YQ23 Study in Patients With Critical Limb Ischaemia
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia.
- Trial name
- YAN (NCT04792008)
- Testing
- YQ23
- Where
- 2 sites in Hong Kong
- Volunteers
- 5 people
- Sponsor
- New Beta Innovation Limited
Peripheral Arterial Disease
Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease
Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an anti-platelet agent for the treatment of PAD.
- Trial name
- NCT03318276
- Testing
- SID142, Rinexin® Tab
- Where
- South Korea
- Volunteers
- 170 people
- Sponsor
- SK Chemicals Co., Ltd.
Atherosclerosis, Hypercholesterolemia
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
- Conditions
- Atherosclerosis, Hypercholesterolemia, Coronary Heart Disease
- Trial name
- NCT00651274
- Testing
- Ezetimibe
- Volunteers
- 144 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Atherosclerosis
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management.
- Trial name
- NCT00651144
- Testing
- Ezetimibe + Rosuvastatin, Rosuvastatin, Ezetimibe
- Volunteers
- 40 people
- Sponsor
- Organon and Co
Peripheral Artery Disease
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or…
- Trial name
- INTENSE (NCT00880230)
- Testing
- Scuba Iliac Stent System
- Where
- 3 sites in United States, Germany
- Volunteers
- 141 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia, Peripheral Arterial Disease
Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease
- Trial name
- RESTORE (NCT03041259)
- Testing
- Rejuveinix Low Dose, Rejuveinix High Dose
- Volunteers
- 320 people
- Sponsor
- Reven Pharmaceuticals, Inc.
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.