Clinical trials: Stricture
Vascular Diseases
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the…
- Trial name
- FLOWGRAFT (NCT05145517)
- Testing
- Open repair
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- JOTEC GmbH
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Renal Artery Obstruction, Hypertension, Renovascular
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury…
- Conditions
- Renal Artery Obstruction, Hypertension, Renovascular, Ischemia Reperfusion Injury
- Trial name
- EVOLVE (NCT01755858)
- Testing
- Bendavia
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Stealth BioTherapeutics Inc.
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Coronary Artery Disease, Native Coronary Artery Stenosis
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
- Trial name
- MAGICAL SV (NCT06271590)
- Testing
- Sirolimus Drug Coated Balloon, Drug eluting stents (DES)
- Where
- 24 sites in United States
- Volunteers
- 1,605 people
- Sponsor
- Concept Medical Inc.
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Urethral Stricture, Urethral Stricture, Anterior
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Lower Urinary Tract Symptoms, Anterior Urethral Stricture
- Trial name
- ROBUST IV (NCT03851952)
- Testing
- Optilume Drug Coated Balloon
- Sponsor
- Urotronic Inc.
Dialysis; Complications, Central Vein Obstruction
APERTO CVS PMCF Study
Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients
- Conditions
- Dialysis; Complications, Central Vein Obstruction, Stenosis, Restenosis
- Trial name
- APERTO CVS (NCT04514406)
- Testing
- APERTO OTW DCB
- Where
- 2 sites in Germany
- Volunteers
- 6 people
- Sponsor
- Cardionovum GmbH
Urethral Stricture
Memokath® 044TW Stent for Treatment of Urethral Stricture
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first…
- Trial name
- NCT00270504
- Testing
- Memokath stenting
- Where
- 7 sites in United States
- Volunteers
- 92 people
- Sponsor
- Pnn Medical DK
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
Renal Artery Stenosis
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.
- Trial name
- NCT00209391
- Testing
- Gadodiamide Injection
- Where
- Germany
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Genitourinary Anatomy
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
This prospective clinical study will evaluate the feasibility, performance, and safety of the LambdaGuide System for obtaining point-to-point measurements of observable genitourinary anatomy during cystoscopic procedures in adult…
- Trial name
- NCT07912385
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lambda Surgical, Inc
Urethral Stricture
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
- Trial name
- STREAM (NCT05383274)
- Testing
- Optilume Urethral DCB
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Urotronic Inc.
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.
Coronary Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
RESPOND EDGE Post Market Study
The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially…
- Trial name
- RESPOND EDGE (NCT04009720)
- Testing
- Lotus Edge Device
- Where
- 13 sites in Denmark, Finland and 7 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation