Clinical trials: Stents
Coronary In-stent Restenosis
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery…
- Trial name
- NCT03373695
- Testing
- Dissolve™, SeQuent®Please
- Where
- 15 sites in China
- Volunteers
- 260 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
BIOFLOW-china Post-marketing Study (BIOTRONIK)
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
- Trial name
- BIOFLOW-China (NCT05667285)
- Testing
- BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 122 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Deep Vein Thrombosis, Bypass Complication
Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or…
- Conditions
- Deep Vein Thrombosis, Bypass Complication, Dialysis Shunt, Stent Occlusion
- Trial name
- P-MAX (NCT03116750)
- Where
- 9 sites in Austria, France and 3 more
- Volunteers
- 81 people
- Sponsor
- Straub Medical AG
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
Cardiac Death, Myocardial Infarction
Leaders Free III: BioFreedom™ Clinical Trial
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
- Conditions
- Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding
- Trial name
- NCT03118895
- Testing
- BioFreedom™ BA9™ drug-coated stent
- Where
- 2 sites in France, Switzerland
- Volunteers
- 404 people
- Sponsor
- Biosensors Europe SA
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
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.
Drug-eluting Stent, Coronary Artery Disease
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions.
- Trial name
- NCT06066450
- Testing
- Genoss® DES system, Genoss® Osfit system
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Thrombosis, Stent Thrombosis
Evaluating Pharmacogenomic Variants for Cardiology Therapeutics
Cipherome's Lighthouse is a clinical decision support tool that incorporates a patient's pharmacogenetic information to determine therapeutic strategy, including determining appropriate dosage or assessing the likelihood of…
- Conditions
- Thrombosis, Stent Thrombosis, Bleeding, Myocardial Infarction
- Trial name
- CARES2 (NCT04702113)
- Testing
- Cipherome Lighthouse Pilot
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cipherome, Inc.
Stent Thrombosis, Ischemic Stroke
Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects
The goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary…
- Conditions
- Stent Thrombosis, Ischemic Stroke, Myocardial Infarction, Acute Coronary Syndrome
- Trial name
- CARES1 (NCT04580602)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Cipherome, 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.
Esophageal Fistula, Esophageal Neoplasms
Removal of the Evolution® Esophageal Stent - Fully Covered
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
- Conditions
- Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis
- Trial name
- CLARITY (NCT01900691)
- Testing
- Evolution® Esophageal Stent - Fully Covered
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- Cook Group Incorporated
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
Coronary Heart Disease, Drug Eluting Stent
Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System
This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results.
- Trial name
- NCT05477940
- Testing
- Absorbable zinc alloy drug eluting coronary stent system
- Volunteers
- 30 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
DES In-stent Stenosis
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent…
- Trial name
- FIMLIMUSDCB (NCT02996318)
- Testing
- Paclitaxel coated balloon (SeQuent Please), Sirolimus coated balloon
- Where
- 5 sites in Malaysia
- Volunteers
- 50 people
- Sponsor
- InnoRa GmbH
Drug-Eluting Stents, Percutaneous Coronary Intervention
Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation
This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in…
- Trial name
- NCT03008083
- Testing
- 3 months DAPT, 12 months DAPT
- Where
- China
- Volunteers
- 2,446 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Disease, Drug Eluting Stent
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal…
- Conditions
- Coronary Disease, Drug Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- NCT03287167
- Testing
- 1 month DAPT, 6 months DAPT
- Where
- China
- Volunteers
- 1,720 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
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 In-stent Restenosis
Trial for MicroPort's DCB
This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent…
- Trial name
- NCT04386213
- Testing
- coronary artery in-stent restenosis
- Volunteers
- 216 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease
EXCEL Clinical Trial
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with…
- Conditions
- Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205776)
- Testing
- Percutaneous Coronary Intervention, CABG
- Where
- United States
- Volunteers
- 1,905 people
- Sponsor
- Abbott Medical Devices