Clinical trials: Stricture
de Novo or Restenosis Lesions
MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: A mounted Cobalt Chromium (CoCr) alloy based stent A Rapid Exchange (RX) Coronary System Delivery System A Poly…
- Trial name
- JNIR (NCT02828917)
- Testing
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
- Where
- Japan
- Volunteers
- 104 people
- Sponsor
- Medinol Ltd.
Hypertrophic Cardiomyopathy
Hypertrophic Regression With N-Acetylcysteine in HCM
The purpose of the sudy is to conduct a small study to gather the preliminary data for future lage scale clinical studies that will be designed test the potential beneficial effect of over-the counter study anti-oxidant drug…
- Trial name
- HALT (NCT01537926)
- Testing
- N-acetylcysteine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- The University of Texas Health Science Center, Houston
Carotid Artery Plaque
99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image…
- Trial name
- NCT02667457
- Testing
- 99mTc-rhAnnexin V-128
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Advanced Accelerator Applications
Lumbar Spinal Stenosis
Vertos Mild - Post Market Patient Outcomes
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.
- Trial name
- NCT01076244
- Testing
- Minimally Invasive Lumbar Decompression
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- The Center for Pain Relief, Inc.
Lumbar Spinal Stenosis
Lumbar Stenosis Outcomes Research II
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain…
- Trial name
- LUSTORII (NCT00652093)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Rochester
Exercise Induced Asthma
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by…
- Trial name
- NCT00127166
- Testing
- Montelukast sodium, Salmeterol xinafoate, Fluticasone propionate
- Volunteers
- 154 people
- Sponsor
- Organon and Co
Symptomatic Aortic Stenosis
Portico TAVI Implant With Transfemoral Delivery System
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
- Trial name
- NCT01493284
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 14 sites in Australia, Denmark and 3 more
- Volunteers
- 222 people
- Sponsor
- Abbott Medical Devices
Coronary Stenosis
BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure.
- Trial name
- NCT03702608
- Testing
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Medinol Ltd.
Aortic Stenosis
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of…
- Trial name
- NCT01319799
- Testing
- Open heart surgery
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Sahlgrenska University Hospital
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Carotid Stenosis
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.
- Trial name
- NCT04326842
- Testing
- Carotid artery revascularization procedure, Optical coherence tomography angiography
- Where
- China
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Harbin Medical University
Heart Diseases, Coronary Artery Disease
Intraoperative Echocardiography in Low-Risk CABG Surgery
This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.
- Conditions
- Heart Diseases, Coronary Artery Disease, Chest Pain, Stenosis Coronary
- Trial name
- NCT06154265
- Testing
- TEE probe
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Pennsylvania
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Lumbar Spinal Stenosis
The Vertos MILD™ Preliminary Patient Evaluation Study
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for…
- Trial name
- NCT00749073
- Testing
- Minimally Invasive Lumbar Decompression (MILD™)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Vertos Medical, Inc.
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
- Trial name
- NCT01014390
- Testing
- WallFlex Biliary RX Fully Covered Stent System
- Where
- 13 sites in Australia, Austria and 9 more
- Volunteers
- 187 people
- Sponsor
- Boston Scientific Corporation
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Stricture Urethra
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
- Trial name
- ROBUST (NCT03014726)
- Testing
- Urotronic Drug Coated Balloon (DCB)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Urotronic Inc.
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
Degenerative Disc Disease, Spinal Stenosis
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01829997
- Testing
- nanOss Bioactive 3D BVF
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pioneer Surgical Technology, Inc.