Clinical trials: Scaffolding
Coronary Artery Disease
Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry
This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.
- Trial name
- NCT04034121
- Testing
- DESolve Cx drug eluting coronary scaffold system
- Where
- 3 sites in Belgium, Brazil
- Volunteers
- 50 people
- Sponsor
- Elixir Medical Corporation
Wound Heal
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs…
- Trial name
- MOSAIC (NCT06600152)
- Testing
- MAP Wound Matrix, DuoDerm
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tempo Therapeutics
Lymphedema, Edema
LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the…
- Trial name
- NCT04606030
- Testing
- BioBridge® Collagen Matrix, Vascularized Lymph Node Transfer (VLNT)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Fibralign Corporation
Coronary Artery Disease
A First-in-Man Study of the Firesorb BVS (FUTURE-I)
This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time.
- Trial name
- FUTURE-I (NCT02659254)
- Testing
- Sirolimus Target Eluting Bioresorbable Vascular Scaffold
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Single Coronary Vessel Disease
A First-in-Man Study of IBS
The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS.
- Trial name
- IBS-FIM (NCT03509142)
- Testing
- Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Vascular Diseases
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Stenosis, Femoropopliteal Stenosis
- Trial name
- Efemoral I (NCT04584632)
- Testing
- Efemoral Vascular Scaffold System (EVSS)
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- Efemoral Medical, Inc.
Peripheral Vascular Disease
The DESappear Study: Drug Eluting Scaffold
The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary…
- Trial name
- DESappear (NCT02869087)
- Testing
- Akesys Prava Scaffold
- Where
- 11 sites in Austria, Belgium and 2 more
- Volunteers
- 21 people
- Sponsor
- Elixir Medical Corporation
Single Coronary Vessel Disease
A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS.
- Trial name
- NCT03616132
- Testing
- Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
- Where
- 2 sites in Malaysia
- Volunteers
- 15 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Rotator Cuff Tear
Use of Graft Jacket for Rotator Cuff Repair
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is…
- Trial name
- NCT00456781
- Testing
- Augmentation, Rotator Cuff Repair without augmentation
- Where
- 7 sites in United States, Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Coronary Artery Disease
FANTOM Post Market Clinical Trial
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
- Trial name
- NCT03587922
- Testing
- Fantom
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 1,500 people
- Sponsor
- REVA Medical, Inc.
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
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent
The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- RENASCENT II (NCT02568462)
- Testing
- AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 12 sites in Colombia, Italy
- Volunteers
- 60 people
- Sponsor
- Amaranth Medical Inc.
Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Trial name
- STANCE (NCT01403077)
- Testing
- 480 Biomedical Bioresorbable Scaffold System
- Where
- 6 sites in Australia, Austria and 2 more
- Volunteers
- 46 people
- Sponsor
- 480 Biomedical
Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
- Trial name
- NCT06968845
- Testing
- LTI-03, Dry Powder Inhaler
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 120 people
- Sponsor
- Rein Therapeutics
Coronary Artery Disease
Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions
This is a prospective, open-label, multicentre, randomized, non-inferiority clinical trial to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System versus Contemporary…
- Trial name
- MeRethonRCT (NCT05417893)
- Testing
- MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Pectus Excavatum
Pectus Excavatum Camouflage
The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction".
- Trial name
- NCT05451108
- Testing
- PCL Pectus Scaffold implantation and autologous fat grafting
- Where
- Australia
- Volunteers
- 7 people
- Sponsor
- BellaSeno Pty Ltd
Injury, Spinal Cord
Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates…
- Trial name
- INSPIRE 2 (NCT03762655)
- Testing
- Neuro-Spinal Scaffold
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics