Clinical trials: Stricture
Carotid Stenosis
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
- Trial name
- NCT01569594
- Testing
- CorMatrix ECM for Carotid Repair
- Where
- 6 sites in United States
- Volunteers
- 230 people
- Sponsor
- Elutia Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Coronary Artery Disease
Coronary MDCTA With Iopamidol Injection 370
Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.
- Trial name
- NCT00558792
- Testing
- Isovue 370, 70 mL, Isovue 370, 80 mL, Isovue 370, 90 mL
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Bracco Diagnostics, Inc
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Cerebral Infarction, Atherosclerosis
Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group.
- Trial name
- TOSS-2 (NCT00130039)
- Testing
- clopidogrel, Cilostazol
- Where
- 19 sites in Hong Kong, Philippines and 2 more
- Volunteers
- 457 people
- Sponsor
- Asan Medical Center
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Intracranial Arterial Stenosis, Intracranial Atherosclerosis
Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis
Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high…
- Conditions
- Intracranial Arterial Stenosis, Intracranial Atherosclerosis, Ischemic Stroke, Cerebral Angiogenesis
- Trial name
- ERSIAS (NCT01819597)
- Testing
- Encephaloduroarteriosynangiosis (EDAS)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Cedars-Sinai Medical Center
Spinal Stenosis
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Trial name
- NCT00534235
- Testing
- Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, Implantation of coflex Interlaminar Technology
- Volunteers
- 322 people
- Sponsor
- Paradigm Spine
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Atherosclerosis, Coronary
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions.
- Trial name
- NCT03149042
- Testing
- CCTA
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- State University of New York at Buffalo
Pain, Postoperative, Urethral Stricture
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior…
- Trial name
- NCT03859024
- Testing
- Oxycodone, Acetaminophen, Gabapentin
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Alabama at Birmingham
Coronary Artery Disease, Coronary Stenosis
FUnctional diagnoSIs of corONary Stenosis (FUSION)
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
- Trial name
- FUSION (NCT04356027)
- Testing
- ICA (Invasive Coronary Angiography), OCT, FFR
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
Background: Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease, Aortic Valve Stenosis
- Trial name
- NCT06269640
- Testing
- Septal Scoring Along Midline Endocardium
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Urethral Stricture
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
- Trial name
- ROBUST-III (NCT03499964)
- Testing
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Where
- 22 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- Urotronic Inc.
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
CoreValve Advance International Post Market Study
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
- Trial name
- NCT01074658
- Testing
- Medtronic CoreValve System
- Where
- 44 sites in Belgium, Colombia and 10 more
- Volunteers
- 1,015 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Renal Artery Stenosis
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
- Trial name
- NCT00631540
- Testing
- Formula Balloon-Expandable Stent
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cook Group Incorporated
Constriction, Pathologic
FLAIR™ Delivery System Study
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
- Trial name
- FLAIR DS (NCT00614315)
- Testing
- FLAIR™ Endovascular Stent Graft
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- C. R. Bard