Clinical trials: Stent Stenosis
Superficial Femoral Artery Stenosis, Atherosclerosis of Femoral Artery
Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions
This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions.
- Trial name
- EPIC SFA BR (NCT01327950)
- Where
- 6 sites in Brazil
- Volunteers
- 86 people
- Sponsor
- Endovascular Consultoria Limitada
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
Coronary Artery Disease
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Coronary Atherosclerotic Disease, Coronary Occlusive Diseases
COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent
The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System.
- Conditions
- Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases, Myocardial Ischemia
- Trial name
- COMPETE (NCT00920283)
- Testing
- Chrono Carbostent Carbofilm™ Coated Coronary Stent, Driver Cobalt Alloy Coronary Stent
- Where
- 6 sites in Italy
- Volunteers
- 205 people
- Sponsor
- CID - Carbostent & Implantable Devices
Chronic Pancreatitis
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
- Trial name
- NCT02802020
- Testing
- Pancreatic fully-covered self-expanding metal stent (FCSEMS)
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 67 people
- Sponsor
- Boston Scientific Corporation
Drug-eluting Stent, Coronary Artery Disease
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions.
- Trial name
- NCT06066450
- Testing
- Genoss® DES system, Genoss® Osfit system
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Biliary Obstruction, Bile Duct Stricture
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY…
- Conditions
- Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases
- Trial name
- NCT04929821
- Testing
- Biliary Duct Stenting
- Where
- 6 sites in Hong Kong, India and 1 more
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Restenosis
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of…
- Conditions
- Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Trial name
- AGENT-ISR (NCT02151812)
- Testing
- Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
- Where
- 12 sites in France, Germany
- Volunteers
- 123 people
- Sponsor
- Hemoteq AG
Carotid Artery Stenoses
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
- Trial name
- NCT02501148
- Testing
- carotid artery stenting
- Where
- 5 sites in Germany
- Volunteers
- 106 people
- Sponsor
- Contego Medical, Inc.
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Renal Artery Obstruction, Hypertension, Renal
The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis
The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled…
- Trial name
- HERCULES (NCT00490841)
- Testing
- Herculink Elite Renal Stent System
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Stenosis
Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.
The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice.
- Trial name
- MER (NCT03133429)
- Testing
- MER
- Where
- 4 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Balton Sp.zo.o.
Carotid Artery Disease, Carotid Stenosis
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under…
- Conditions
- Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
- Trial name
- NCT00287508
- Testing
- Carotid artery stenting with filter (interventional)
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Trial name
- NCT03121430
- Testing
- Drug eluting peripheral vascular stent system, Nitinol Stent System
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Coronary Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Ischemia
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery…
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Coronary Stenosis
- Trial name
- REVERSE (NCT05846893)
- Testing
- SeQuent® Please NEO drug-coated balloon catheter, Current-generation drug-eluting stent
- Where
- 21 sites in Malaysia, Singapore and 2 more
- Volunteers
- 1,436 people
- Sponsor
- B. Braun Medical Industries Sdn. Bhd.
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
Renal Artery Stenosis, Renal Failure
RADIX 2 RENAL STENT Post-Market Retrospective Study
The Carbostent™ Radix 2 stent is a CE marked balloon expandable bare metal stent for the treatment of renal artery stenosis. The aim of this post-market retrospective study protocol P12204, is to collect clinical data on patients…
- Trial name
- RADIX 2 (NCT05612438)
- Testing
- RADIX 2 Stent
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- CID S.p.A.