Clinical trials: Stricture
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Lumbar Spinal Stenosis
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
- Trial name
- PRESS2 (NCT04563793)
- Testing
- Superion™ IDS
- Where
- 23 sites in United States
- Volunteers
- 129 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A prospective, multicenter, nonrandomized, single-arm, clinical study.
- Trial name
- NCT03025971
- Testing
- J-Valve Transcatheter Aortic valve replacement
- Where
- 3 sites in China
- Volunteers
- 107 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Peripheral Artery Disease (PAD)
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries.
- Trial name
- SELECT (NCT06605209)
- Testing
- Peripheral Balloon-Expandable Covered Stent System
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Low Back Pain
Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
ZygoFix has developed a system consisting of zLOCK Facet Fusion System. The zLOCK Facet Fusion System is intended for single level stabilization of a spinal motion segment to promote bonny fusion of the joint.
- Trial name
- NCT04229316
- Testing
- zLOCK Facet Stabilization System
- Where
- Hungary
- Volunteers
- 24 people
- Sponsor
- ZygoFix
Coronary Artery Stenoses, Stable Angina
e-BioMatrix 6 Month DAPT France
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™…
- Conditions
- Coronary Artery Stenoses, Stable Angina, Ischemia, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT03461484
- Volunteers
- 2,098 people
- Sponsor
- Biosensors Europe SA
Treatment of Symptomatic Lateral Sinus Stenosis, Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis
SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
The purpose of the study is to assess the efficacy, safety and the clinical benefit of the SiREX stent for the treatment of disabling pulsatile tinnitus due to stenosis of lateral sinus.
- Trial name
- RESOLVE (NCT06726928)
- Testing
- Sinus Stenting
- Where
- France
- Volunteers
- 78 people
- Sponsor
- Acandis GmbH
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis
A Clinical Study of the Dynesys(R) Spinal System
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
- Conditions
- Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis, Stenosing Lesion.
- Trial name
- NCT00759057
- Testing
- Posterior Pedicle Screw System
- Where
- 26 sites in United States
- Volunteers
- 399 people
- Sponsor
- Zimmer Biomet
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
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY™ Endovascular Stent Graft
This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or thoracic central veins of subjects who…
- Trial name
- NCT03644017
- Testing
- WRAPSODY Stent Graft Placement
- Where
- 3 sites in Greece, United Kingdom
- Volunteers
- 46 people
- Sponsor
- Merit Medical Systems, Inc.
Coronary Artery Disease, Coronary Stenosis
TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment
The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable…
- Trial name
- T-P (NCT04951050)
- Testing
- Rapamycin target eluting stent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
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
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Symptomatic Aortic Stenosis
The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve…
- Trial name
- NCT02536196
- Testing
- Embolic Protection Device, Transcatheter aortic valve implantation (TAVI)
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 478 people
- Sponsor
- Keystone Heart
Vaginal Stenosis, Radiation Therapy
Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies
Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy.
- Conditions
- Vaginal Stenosis, Radiation Therapy, Cancer, Pelvic Pain
- Trial name
- NCT05648253
- Testing
- Hyivy Intravaginal Device
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Hyivy Health Inc
Peripheral Arterial Disease, Peripheral Artery Disease
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
- Trial name
- PREVISION (NCT05556681)
- Testing
- BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
- Where
- 10 sites in Australia, New Zealand and 1 more
- Volunteers
- 34 people
- Sponsor
- C. R. Bard
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI