Clinical trials: Stricture
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Coronary Stenosis
The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy…
- Trial name
- NCT04569669
- Testing
- FFR and FFRCT
- Where
- 8 sites in China
- Volunteers
- 325 people
- Sponsor
- CCRF Inc., Beijing, China
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic…
- Trial name
- PII S3i (NCT03222128)
- Testing
- TAVR
- Where
- 51 sites in United States
- Volunteers
- 1,074 people
- Sponsor
- Edwards Lifesciences
Femoral Artery Stenosis, Popliteal Artery Stenosis
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT05734157
- Testing
- Peripheral PTA with a drug coated balloon
- Where
- 8 sites in France, Germany
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
- Trial name
- SCBDNMAL (NCT04017364)
- Testing
- PCB PTCA, SCB PTCA
- Where
- 6 sites in Malaysia
- Volunteers
- 70 people
- Sponsor
- InnoRa GmbH
Aortic Valve Stenosis
Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
- Trial name
- NCT04703699
- Testing
- Myval Transcatheter Heart Valve Series
- Where
- 8 sites in Estonia, Italy and 5 more
- Volunteers
- 200 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Degenerative Disc Disease, Spinal Stenosis
Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
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
- NCT01452516
- Testing
- nanOss Bioactive Bone void filler, Interbody FCage
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
Degenerative Disc Disease, Kyphosis
Post-Market Clinical Follow-up Study of A-SPINE's Products
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before…
- Conditions
- Degenerative Disc Disease, Kyphosis, Scoliosis, Trauma
- Trial name
- NCT04848376
- Testing
- (1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- A-Spine Asia Co., Ltd.
Carotid Stenosis
[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for carotid plaque imaging and will be conducted as a Phase II trial since this compound has already been tested in humans for phase I and phase…
- Trial name
- NCT01602471
- Testing
- [F-18]RDG-K5
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Siemens Molecular Imaging
Intracranial Stenosis
AcandiS Stenting of Intracranial STENosis - regisTry
ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.
- Trial name
- ASSISTENT (NCT03902444)
- Testing
- Credo® Stent, NeuroSpeed® PTA balloon catheter
- Where
- 16 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Acandis GmbH
Coronary Artery Stenosis
Angiography Study of BioNIR Drug Eluting Stent System (NIREUS)
The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter…
- Trial name
- NIREUS (NCT01995500)
- Testing
- BioNIR, Resolute
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Medinol Ltd.
Coronary Artery Disease(CAD)
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and…
- Trial name
- NCT07439133
- Testing
- XTR004
- Where
- 5 sites in China
- Volunteers
- 395 people
- Sponsor
- Sinotau Pharmaceutical Group
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Spinal Stenosis
Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc…
- Trial name
- NCT01485289
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Rachiotek LLC
Coronary Artery Disease
Prospective multicEntric NonranDomized Registry
The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus Eluting stent system in patients with de novo coronary lesions.
- Trial name
- ExPEND (NCT02496169)
- Testing
- eucaLimus
- Volunteers
- 400 people
- Sponsor
- Eucatech AG
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery