Clinical trials: PCI
Graft Versus Host Disease (GVHD)
Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
- Trial name
- NCT04167514
- Testing
- Alpha-1 antitrypsin (AAT)
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- CSL Behring
STEMI - ST Elevation Myocardial Infarction
Asian Registry of the BioFreedom Stent for STEMI Patients
The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia.
- Trial name
- NCT03609346
- Testing
- PCI
- Where
- 5 sites in Hong Kong, Singapore and 3 more
- Volunteers
- 914 people
- Sponsor
- Biosensors Europe SA
Atherosclerosis, Coronary Artery Disease
XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting…
- Trial name
- EXCEED (NCT00731237)
- Where
- 44 sites in United States
- Volunteers
- 2,517 people
- Sponsor
- Abbott Medical Devices
Type 1 Diabetes Mellitus
Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus
Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its anti-inflammatory properties.
- Trial name
- NCT01304537
- Testing
- Alpha-1 Antitrypsin 40mg (AAT, Glassia®), Alpha-1 Antitrypsin 60mg (AAT, Glassia®), Alpha-1 Antitrypsin 80mg (AAT, Glassia®)
- Where
- 2 sites in Israel
- Volunteers
- 24 people
- Sponsor
- Kamada, Ltd.
Optical Biometer, Cataracts
Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
- Trial name
- BIO-CAT-DENSA (NCT05239715)
- Testing
- Ocular biometry
- Where
- Spain
- Volunteers
- 51 people
- Sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
Cystic Fibrosis
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients
Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction…
- Trial name
- NCT00499837
- Testing
- Aerosolized, human, plasma-derived Alpha-1 Antitrypsin
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Kamada, Ltd.
Angiocardiography
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good…
- Trial name
- TRUST (NCT01206257)
- Testing
- Iopromide (Ultravist, BAY86-4877)
- Where
- China
- Volunteers
- 17,513 people
- Sponsor
- Bayer
Cardiogenic Shock, High Risk PCI
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
- Trial name
- NCT05820451
- Testing
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution
- Where
- 20 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abiomed Inc.
PCI Patients
Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients
Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to…
- Trial name
- NCT02561845
- Testing
- rosuvastatin
- Sponsor
- AstraZeneca
Coronary Artery Disease
Deutsches Dual Therapy Stent Register
The DTS.DE registry is an initiative for the collection of high quality process and historical data of implantations with the COMBO Dual Therapy Stent in Germany.
- Trial name
- DTS Register (NCT02102997)
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- OrbusNeich
New Onset Type-1 Diabetes
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.
- Trial name
- NCT02005848
- Testing
- Alpha-1 Antitrypsin
- Where
- 4 sites in Israel
- Volunteers
- 70 people
- Sponsor
- Kamada, Ltd.
Acute Coronary Syndrome, High Bleeding Risk
LEADERS FREE II: BioFreedom™ Pivotal Study
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
- Trial name
- NCT02843633
- Testing
- BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
- Where
- 66 sites in United States, Canada and 5 more
- Volunteers
- 1,203 people
- Sponsor
- Biosensors Europe SA
Type 1 Diabetes Mellitus
Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with…
- Trial name
- NCT02093221
- Testing
- 180 mg/kg Alpha1-PI, 90 mg/kg Alpha1-PI
- Where
- 36 sites in United States
- Volunteers
- 76 people
- Sponsor
- Grifols Therapeutics LLC
Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly…
- Conditions
- Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease, Graft-versus-host-disease, Graft Vs Host Disease
- Trial name
- NCT03172455
- Testing
- Glassia
- Sponsor
- Impatients N.V. trading as myTomorrows
Acute-graft-versus-host Disease
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or…
- Trial name
- MODULAATE (NCT03805789)
- Testing
- AAT
- Where
- 34 sites in United States, Australia and 6 more
- Volunteers
- 222 people
- Sponsor
- CSL Behring
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD III With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic…
- Trial name
- NCT03595176
- Testing
- Lithotripsy
- Where
- 48 sites in United States, France and 2 more
- Volunteers
- 431 people
- Sponsor
- Shockwave Medical, Inc.