Clinical trials: Drug Eluting Stents
Coronary Disease
A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)
To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting…
- Trial name
- NCT00322569
- Testing
- Corio™ Pimecrolimus-Eluting Coronary Stent System, SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System, Costar ™ Paclitaxel-Eluting Coronary Stent System
- Where
- United Kingdom
- Volunteers
- 246 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Myocardial Ischemia
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery…
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Coronary Stenosis
- Trial name
- REVERSE (NCT05846893)
- Testing
- SeQuent® Please NEO drug-coated balloon catheter, Current-generation drug-eluting stent
- Where
- 21 sites in Malaysia, Singapore and 2 more
- Volunteers
- 1,436 people
- Sponsor
- B. Braun Medical Industries Sdn. Bhd.
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, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)
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 III (NCT02900937)
- Testing
- AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 13 sites in Colombia, Italy
- Volunteers
- 70 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete…
- Trial name
- DESSOLVE-II (NCT01294748)
- Testing
- MiStent DES, Endeavor DES
- Where
- 28 sites in Belgium, France and 4 more
- Volunteers
- 184 people
- Sponsor
- Micell Technologies
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoint of late lumen loss and…
- Trial name
- BIOFLOW-I (NCT01214148)
- Testing
- ORSIRO - Drug Eluting Coronary Stent
- Where
- 2 sites in Romania
- Volunteers
- 30 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute…
- Trial name
- DIRECT II (NCT01788150)
- Testing
- Coronary Stenting
- Where
- 18 sites in Belgium, Czechia and 5 more
- Volunteers
- 159 people
- Sponsor
- Svelte Medical Systems, Inc.
Stable Angina, Silent Myocardial Ischemia
Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.
The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in…
- Conditions
- Stable Angina, Silent Myocardial Ischemia, Acute Coronary Syndrome
- Trial name
- SENIOR (NCT02099617)
- Testing
- Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
- Where
- 44 sites in Belgium, Finland and 7 more
- Volunteers
- 1,200 people
- Sponsor
- Ceric Sàrl
Heart Diseases
Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man Study
The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent…
- Trial name
- NCT02844270
- Testing
- Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Volunteers
- 45 people
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
Coronary Artery Disease, Drug Eluting Balloon
Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial
The main objective of the SPARX trial is to compare paclitaxel-coated balloons to with contemporary DES in complex and small coronary artery lesions in patients with NSTEACS or CCS; the co-primary objective is to compare two…
- Conditions
- Coronary Artery Disease, Drug Eluting Balloon, Drug Eluting Stent
- Trial name
- SPARX RCT (NCT07397845)
- Testing
- Protégé and Protégé NC, Agent, Drug Eluting Stent
- Where
- Switzerland
- Volunteers
- 1,380 people
- Sponsor
- Translumina GmbH
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
Myocardial Ischemia, Coronary Artery Stenosis
SPIRIT PRIME Clinical Trial
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due…
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- SPIRIT PRIME (NCT00916370)
- Testing
- Core size Xience Prime, Xience Prime Long Lesion (LL)
- Where
- 62 sites in United States, Australia
- Volunteers
- 525 people
- Sponsor
- Abbott Medical Devices
Coronary Stenosis
Excel Drug-Eluting Stent Pilot Clinical Registry
The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
- Trial name
- NCT00385905
- Testing
- Excel Drug-eluting stent
- Where
- China
- Volunteers
- 100 people
- Sponsor
- JW Medical Systems Ltd
Atherosclerotic Lesion(s)
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in the treatment of subjects…
- Trial name
- EVOLVE II QCA (NCT01787799)
- Testing
- SYNERGY
- Where
- 13 sites in Australia, Japan and 2 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2…
- Trial name
- NCT05033964
- Testing
- Percutaneous Coronary Intervention with drug eluting stents
- Where
- 14 sites in Belgium, Brazil and 3 more
- Volunteers
- 200 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
The Optical Coherence Tomography Drug Eluting Stent Investigation
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index…
- Trial name
- OCTDESI (NCT00776204)
- Testing
- JACTAX Drug eluting stent, JACTAX LD drug eluting stent, Taxus Libertè
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Coronary Atherosclerosis
Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries.
- Trial name
- NEVO RES-I (NCT00606333)
- Testing
- NEVO™ Sirolimus-eluting Coronary Stent System, Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
- Where
- 2 sites in Brazil, New Zealand
- Volunteers
- 394 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for…
- Trial name
- ENDEAVOR III (NCT00217256)
- Testing
- Percutaneous Coronary Stenting
- Volunteers
- 436 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
- Trial name
- BABILON (NCT01278186)
- Testing
- Balloon angioplasty, Stent implantation
- Where
- 9 sites in Spain
- Volunteers
- 190 people
- Sponsor
- B.Braun Surgical SA