Clinical trials: Coronary Artery In-stent Restenosis
Coronary Artery Disease
The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis
This study consisted of a randomized controlled trial group and a long balloon observation group. In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the…
- Trial name
- NCT04733443
- Testing
- Biolimus, SeQuent® Please Neo
- Where
- China
- Volunteers
- 310 people
- Sponsor
- JW Medical Systems Ltd
Coronary Disease, Coronary Artery Disease
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT V (NCT00402272)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- 93 sites in Austria, Belgium and 21 more
- Volunteers
- 2,700 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
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
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
Coronary Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, In Stent Restenosis
Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
- Trial name
- SIBLINT ISR (NCT04240444)
- Testing
- drug-coated balloon Catheter
- Where
- 16 sites in China
- Volunteers
- 260 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB B (NCT00856856)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 12 sites in Australia, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR
The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).
- Trial name
- NCT04767022
- Testing
- Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent
The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control…
- Conditions
- Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary, Stents
- Trial name
- MARTIN (NCT00637104)
- Testing
- Mar-Tyn TiN coated Co-Cr Numen stent implant, Vision Co-Cr stent implant
- Where
- 7 sites in Germany, Italy and 2 more
- Volunteers
- 160 people
- Sponsor
- International Biomedical Systems S.p.A.
Coronary Artery Disease
SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent
The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as…
- Trial name
- NCT00917163
- Testing
- Supralimus(R) Sirolimus-Eluting Coronary Stent System, Xience V™ Everolimus Eluting Coronary Stent
- Where
- 28 sites in Brazil, India and 1 more
- Volunteers
- 13 people
- Sponsor
- Sahajanand Medical Technologies Limited
In-Stent Restenosis, Cardiovascular Diseases
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
- Conditions
- In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- MAGICAL ISR (NCT05908331)
- Testing
- Sirolimus Drug Coated Balloon, Plan balloon Angioplasty (POBA)
- Where
- 28 sites in United States
- Volunteers
- 492 people
- Sponsor
- Concept Medical Inc.
In-Stent Restenosis or De Novo Coronary Artery Lesions
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system.
- Trial name
- NCT07415902
- Testing
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Where
- China
- Volunteers
- 252 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, In-Stent Restenosis
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.
- Trial name
- REFORM (NCT04079192)
- Testing
- Biolimus A9 Drug Coated Balloon, SeQuent Please Paclitaxel Drug Coated Balloon
- Where
- 15 sites in Germany, Ireland and 3 more
- Volunteers
- 201 people
- Sponsor
- Biosensors Europe SA
In-stent Restenosis, Ischemic Heart Disease
The PREVAIL Study
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with…
- Conditions
- In-stent Restenosis, Ischemic Heart Disease, Coronary Artery Disease
- Trial name
- PREVAIL (NCT03260517)
- Testing
- Medtronic Coronary Drug-Coated Balloon Catheter
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Vascular