Clinical trials: Stricture
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
Coronary Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 people
- Sponsor
- Abbott Medical Devices
Pyloric Stenosis
Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital.
- Trial name
- NCT03650842
- Testing
- Near infrared spectroscopy (NIRS)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nationwide Children's Hospital
Pulmonary Veno Occlusive Disease
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.
- Trial name
- PVS (NCT00891527)
- Testing
- Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Children's Hospital
Carotid Artery Stenosis
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
- Trial name
- NCT03816202
- Testing
- Sundt carotid shunt
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Carotid Stenosis, Constriction, Pathologic
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders
- Trial name
- FREEDOM (NCT01343667)
- Testing
- Gore Flow Reversal System, Gore Embolic Filter
- Where
- 39 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- W.L.Gore & Associates
Lumbar Spinal Stenosis
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS).
- Trial name
- NCT00534092
- Testing
- X STOP® Interspinous Process Decompression System
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Medtronic Spine LLC
Vaginal Stricture
Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
Each year, females need surgery to create a vaginal canal or pelvic radiation to treat cancer. The result is often a narrowing or scarring of their vagina. To aid in healing a stent is often placed.
- Trial name
- NCT04807387
- Testing
- Vaginal Stent A, Vaginal Stent B, Vaginal Stent
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Mitral Annular Calcification
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at…
- Trial name
- SITRAL (NCT02830204)
- Testing
- Mitral Valve Replacement (MVR) with Sapien3
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute
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
Urethral Stricture
Clostridium Histolyticum Collagenase Injection for Urethral Disease
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
- Trial name
- NCT02948842
- Testing
- Clostridium Histolyticum Collagenase, Saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of South Florida
Stents, Coronary Artery Disease
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V®…
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis
- Trial name
- NCT00180479
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 1,002 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Peripheral Artery Disease, Femoropopliteal Artery Stenosis
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- Trial name
- STRONG (NCT01154751)
- Testing
- SUPERA Interwoven self-expanding nitinol stent
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
Coronary Stenosis
Study Comparing the MiStent SES Versus the XIENCE EES Stent
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease.
- Trial name
- DESSOLVE III (NCT02385279)
- Testing
- MiStent, XIENCE EES
- Where
- 20 sites in France, Germany and 2 more
- Volunteers
- 1,398 people
- Sponsor
- ECRI bv
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.
Arteriovenous Fistula Stenosis
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous…
- Trial name
- NCT05034939
- Testing
- FLEX Vessel Prep System, Angioplasty
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- VentureMed Group Inc.
Myocardial Ischemia, Coronary Artery Stenosis
SPIRIT PRIME Clinical Trial
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due…
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- SPIRIT PRIME (NCT00916370)
- Testing
- Core size Xience Prime, Xience Prime Long Lesion (LL)
- Where
- 62 sites in United States, Australia
- Volunteers
- 525 people
- Sponsor
- Abbott Medical Devices
Obstructive Hypertrophic Cardiomyopathy
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM).
- Trial name
- EXPLORER-HCM (NCT03470545)
- Testing
- mavacamten
- Where
- 71 sites in United States, Belgium and 11 more
- Volunteers
- 251 people
- Sponsor
- MyoKardia, Inc.