Clinical trials: Vascular Lesion
Coronary Artery Disease
Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360709
- Testing
- CRE8 sirolimus-eluting stent
- Where
- China
- Volunteers
- 800 people
- Sponsor
- CID S.p.A.
Contraception, Female Contraception
Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.
This study uses the PharMetrics and MarketScan US health care insurance claims database to estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus thrombosis), ischemic stroke, and acute…
- Conditions
- Contraception, Female Contraception, Fertility Control
- Trial name
- NCT00511784
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Coronary Artery Disease
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
- Trial name
- BIFURCATION (NCT00234455)
- Testing
- drug eluting-stent, drug-eluting stent
- Where
- Italy
- Volunteers
- 86 people
- Sponsor
- Cordis US Corp.
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Small Vessel Lesion
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)
Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter VasoguardTM in treatment of small vessel lesion.
- Trial name
- NCT02891005
- Testing
- paclitaxel controlled release balloon catheter (VasoguardTM), common balloon catheter (Maverick2)
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Atherosclerotic Heart Disease
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
- Trial name
- NCT01816854
- Testing
- Stenting
- Where
- Belgium
- Volunteers
- 117 people
- Sponsor
- be Medical
Coronary Artery Disease
Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions
This is a prospective, open-label, multicentre, randomized, non-inferiority clinical trial to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System versus Contemporary…
- Trial name
- MeRethonRCT (NCT05417893)
- Testing
- MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Cardiovascular Disease, de Novo Coronary Lesions
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical…
- Trial name
- ARRIVE 2 (NCT00569751)
- Testing
- TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
- Where
- 53 sites in United States
- Volunteers
- 5,016 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Everolimus
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK…
- Conditions
- Coronary Artery Disease, Everolimus, Vascular Disease, Myocardial Ischemia
- Trial name
- NCT00180453
- Testing
- Coronary artery drug eluting stent placement, Coronary artery stent placement
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Chronic Total Occlusion of Coronary Artery
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional…
- Trial name
- NCT01978860
- Testing
- NovaCross, CTO
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- Chanan Schneider
Coronary Artery Disease
NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial
The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective, multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable coronary scaffold with XIENCE PRIME Everolimus…
- Trial name
- NCT02305485
- Testing
- NeoVas BCS, XIENCE PRIME EECSS
- Where
- 27 sites in China
- Volunteers
- 560 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Aortic Aneurysm, Thoracic, Pseudoaneurysm
Evaluation of the GORE® Ascending Stent Graft
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
- Conditions
- Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
- Trial name
- ARISEII (NCT05800743)
- Testing
- GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device), Surgery
- Where
- 41 sites in United States
- Volunteers
- 370 people
- Sponsor
- W.L.Gore & Associates
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
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
Coronary Artery Disease (CAD)
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon
The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated…
- Trial name
- PASSWORD (NCT02554292)
- Testing
- Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
- Where
- Germany
- Volunteers
- 481 people
- Sponsor
- B. Braun Melsungen AG
Coronary Artery Disease (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Peripheral Artery Disease
BRight DCB First-in-Human Study
The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
- Trial name
- NCT04525794
- Testing
- BRight DCB
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 48 people
- Sponsor
- Biotronik CRC Inc.
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation