Clinical trials: de Novo
Heart and Lung Transplant
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2…
- Trial name
- NCT00154193
- Testing
- cyclosporine
- Where
- Switzerland
- Volunteers
- 190 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study
Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts…
- Trial name
- NCT02970630
- Testing
- Tacrolimus, Everolimus
- Where
- 6 sites in Italy
- Volunteers
- 28 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
Renal Transplantation
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing…
- Trial name
- Senator (NCT00956293)
- Testing
- Basiliximab, Enteric Coated Mycophenolic Acid (MPA), RAD001
- Where
- 9 sites in Germany
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Artery Disease
DESolve Post-Approval Study
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Trial name
- NCT02013349
- Testing
- coronary intervention
- Where
- 7 sites in Germany, Italy and 1 more
- Volunteers
- 102 people
- Sponsor
- Elixir Medical Corporation
Kidney Transplantation, Graft Rejection
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
- Trial name
- NCT00251004
- Testing
- Everolimus, Mycophenolic Acid (MPA), Cyclosporine A (CsA)
- Where
- United States
- Volunteers
- 833 people
- Sponsor
- Novartis
Coronary Artery Disease
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary…
- Trial name
- OPC (NCT02698852)
- Testing
- BuMA Supreme
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sino Medical Sciences Technology Inc.
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
de Novo Lesions in Native Coronary Arteries
First in Man Trial - BIOSOLVE-I
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
- Trial name
- BIOSOLVE-I (NCT01168830)
- Testing
- AMS-3.0
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 46 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system
- Trial name
- NCT00180583
- Testing
- Guidant GALILEO Intravascular Radiotherapy System
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Abbott Medical Devices
Left Main Coronary Artery Stenosis
eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries
The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both…
- Trial name
- eTRYTONLM (NCT02765646)
- Testing
- Coronary stent procedure (CSP)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.
Coronary Artery Disease
A Trial of DCB vs DES in the Treatment of de Novo Large Diameter Coronary Atherosclerotic Stenosis(LARGE ONE)
For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention (PCI), the use of a drug balloon (DCB) is not inferior to the placement of a drug-eluting stent (Firehawk™ family).
- Trial name
- LARGE-ONE (NCT05961787)
- Testing
- SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)
- Where
- China
- Volunteers
- 134 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Renal Transplant
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival.
- Trial name
- NCT00149929
- Testing
- Mycophenolate sodium (enteric coated)
- Volunteers
- 246 people
- Sponsor
- Novartis
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerosis, Coronary Artery Disease
The OMEGA Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
- Trial name
- NCT01419171
- Testing
- OMEGA™ Monorail Coronary Stent System
- Where
- 37 sites in United States, Belgium and 5 more
- Volunteers
- 328 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion…
- Trial name
- NCT02086045
- Testing
- DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Where
- 13 sites in Belgium, Brazil and 4 more
- Volunteers
- 126 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel…
- Trial name
- RI-US XL (NCT01913600)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Medtronic Vascular