Clinical trials: Covered Stent
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Iliac Artery Disease, Peripheral Artery Disease
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients…
- Trial name
- NCT04822727
- Testing
- 1 or more AndraTec devices (see description for list of devices)
- Sponsor
- Dr. Sabrina Overhagen
Coronary Artery Disease, Myocardial Infarction
Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Stent Implantation
Coronary artery disease is one of the most prevalent diseases in the western countries. A waxy substance called plaque can build up inside the coronary arteries.
- Trial name
- OCTACS (NCT02272283)
- Testing
- Percutaneous coronary intervention with Nobori biolimus-eluting stent implantation
- Volunteers
- 100 people
- Sponsor
- Odense University Hospital
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
Coronary Artery Disease
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event.
- Trial name
- NCT01024179
- Testing
- Polymer-based sirolimus-eluting stent (Partner stent )
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Harbin Medical University
Coronary Artery Disease
Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography
Neointimal coverage over stent strut is important for preventing the stent thrombosis. But, there is no data for the duration of complete formation of neointima om zotarolimus eluting stent (ZES).
- Trial name
- ENDEAVOR OCT (NCT00815139)
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Yonsei University
Mesenteric Ischemia, Bowel; Ischemic
Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition.
- Conditions
- Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis, Mesenteric Artery Stenosis
- Trial name
- COMESS (NCT05244629)
- Testing
- BMS vs. CS
- Where
- Denmark
- Volunteers
- 98 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Atherosclerotic Renal Artery Stenosis, Hypertension
Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis
Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications.
- Conditions
- Atherosclerotic Renal Artery Stenosis, Hypertension, Renal Artery Stenosis
- Trial name
- COMBAT (NCT07566065)
- Testing
- Covered Stent, Bare Metal Stent
- Where
- 15 sites in China
- Volunteers
- 150 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Biliary Strictures Caused by Malignant Neoplasms
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary…
- Trial name
- NCT00713427
- Testing
- WallFlex™ Biliary Partially-Covered Stent
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Necrosis
Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents
The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic…
- Trial name
- NCT02673541
- Testing
- AXIOS™ stent, Double Pigtail Stents
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Acute Coronary Syndrome
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for…
- Trial name
- BASE-OCT (NCT01080859)
- Testing
- OCT
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- The Hospital District of Satakunta
Coronary Artery Disease, Coronary Disease
Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI
The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™…
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- NCT02770651
- Testing
- Everolimus-Eluting stent, Zotarolimus-Eluting stent
- Where
- South Korea
- Volunteers
- 69 people
- Sponsor
- Keimyung University Dongsan Medical Center
Esophageal Cancer, Esophageal Stenosis
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia.
- Trial name
- COPAC (NCT01661686)
- Testing
- Partially covered SEMS, Fully covered SEMS
- Where
- 5 sites in Netherlands
- Volunteers
- 98 people
- Sponsor
- Foundation for Liver Research
Carotid Artery Diseases
OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent
Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound [IVUS, 20MHz electronic phase-array transducer] to document the procedure result of an effective…
- Trial name
- OPTIMA (NCT04234854)
- Testing
- Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- John Paul II Hospital, Krakow
Coarctation of the Aorta
Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
- Trial name
- CoA-ICS-I (NCT07316855)
- Testing
- Implantation of Bioresorbable Iron-based Covered Aortic Stent
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shubo Song
Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%)
The SIBERIA Trial (Acculink™ Versus CGuard™)
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Trial name
- CAS (NCT03488199)
- Testing
- Stent Acculink ™, CGuardTM™
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Pancreaticobiilary Diseases, Endoscopic Retrograde Cholangiopancreatography
Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation.
- Trial name
- NCT04325152
- Testing
- FCSEMS plus Clip, FCSEMS
- Where
- 5 sites in China
- Volunteers
- 180 people
- Sponsor
- Air Force Military Medical University, China
Carotid Stenosis, Coronary Artery Disease
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart…
- Conditions
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction
- Trial name
- SIM-GUARD (NCT04973579)
- Testing
- Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Biliary Obstruction
Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction
Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement.
- Trial name
- METARSI (NCT04431427)
- Testing
- Biliary drainage with PC-SEMS, Biliary drainage with U-SEMS
- Volunteers
- 300 people
- Sponsor
- Santi Mangiafico
Aorto-iliac Aneurysms, Iliac Aneurysms
Zenith(R) Connection Endovascular Covered Stent Clinical Study
The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch…
- Trial name
- NCT00893620
- Testing
- Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
- Where
- 4 sites in Germany, Hong Kong and 1 more
- Volunteers
- 1 people
- Sponsor
- Cook Group Incorporated