Clinical trials: Restenosis, Coronary
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 Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Trial name
- XVU-Phase 1 (NCT00676520)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- United States
- Volunteers
- 8,053 people
- Sponsor
- Abbott Medical Devices
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.
Coronary Artery Disease
SONICURE（SONICracker for the Treatment of UndeRExpansion）
The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery.
- Trial name
- NCT06924736
- Testing
- Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter, Non - compliant balloon dilatation catheter
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Treatment of Symptomatic Ischemic Heart Disease
The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)
Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20 January 2004 and 26 May 2004, were treated with 10…
- Trial name
- NCT00974181
- Testing
- Conor Medsystems COSTAR™ stent (10 µg Paclitaxel), Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)
- Where
- Italy
- Volunteers
- 282 people
- Sponsor
- Cordis US Corp.
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
Coronary Artery Disease, Coronary Restenosis
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs.
- Trial name
- AbsorbISR (NCT02474485)
- Testing
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography.
- Where
- Switzerland
- Volunteers
- 53 people
- Sponsor
- SIS Medical AG
Coronary Artery Disease
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent…
- Trial name
- NCT04405063
- Testing
- Paclitaxel Coated PTCA Balloon Catheter
- Volunteers
- 82 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
Coronary Artery Disease
The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.
- Trial name
- NCT01368627
- Testing
- Supralimus® Sirolimus-Eluting Coronary Stent
- Where
- 7 sites in Brazil
- Volunteers
- 1,274 people
- Sponsor
- Sahajanand Medical Technologies Limited
In-stent Coronary Artery Restenosis
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
- Trial name
- PEPPER (NCT00961181)
- Testing
- Paclitaxel Releasing Balloon
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
In Stent ELUTES Study
This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.
- Trial name
- ELUTES II (NCT00225680)
- Testing
- drug eluting coronary stent
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Cook Group Incorporated
Coronary Artery Disease
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.
- Trial name
- NCT01308346
- Testing
- Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
In-stent Restenosis
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter
Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.
- Trial name
- NCT02891018
- Testing
- paclitaxel controlled release balloon catheter Vasoguard TM, paclitaxel release coronary balloon catheter SeQuent Please
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Coronary Artery Disease
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound…
- Trial name
- MAGIC-TOUCH (NCT02400632)
- Testing
- MAGIC-TOUCH Drug-eluting Balloon
- Where
- 3 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Occlusion, Thrombosis (Stent Thrombosis)
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System…
- Conditions
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia
- Trial name
- NCT01178268
- Testing
- XIENCE V EECSS, CYPHER SELECT PLUS SECSS
- Where
- 2 sites in China
- Volunteers
- 546 people
- Sponsor
- Abbott Medical Devices
Angina Pectoris, Coronary Artery Disease
A Safety Study of ABI-007 for In-Stent Restenosis
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries.
- Trial name
- NCT00093223
- Testing
- Paclitaxel Nanoparticle Albumin Bound
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Celgene
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Coronary Artery Disease
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion…
- Trial name
- NCT00232804
- Testing
- Bx Cypher stent
- Where
- France
- Volunteers
- 639 people
- Sponsor
- Cordis US Corp.