Clinical trials: Drug Eluting Stents
Coronary Artery Disease
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however…
- Trial name
- DCB-CTO (NCT07369765)
- Testing
- Drug-Eluting Stent Group, Drug Coated Balloon Group
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Biruni University
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
Peripheral Arterial Disease
Zilver PTX Drug-Eluting Peripheral Stent Study
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee…
- Trial name
- NCT01348425
- Testing
- Longer Zilver PTX Stents, Shorter Zilver PTX Stents
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 45 people
- Sponsor
- Cook Group Incorporated
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- K-ELUVIA (NCT06234280)
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Chronic Coronary Occlusion, Vascular Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
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…
- Conditions
- Chronic Coronary Occlusion, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-LTF (NCT01120379)
- Testing
- XIENCE V® EECSS
- Where
- United States
- Volunteers
- 5,034 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Atherosclerosis
Drug-eluting Balloon in Bifurcations Trial
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina
- Trial name
- DEBIUT (NCT00857441)
- Testing
- Drug eluting balloon, Liberté, PTCA balloon catheter
- Where
- 3 sites in Belgium, Netherlands
- Volunteers
- 120 people
- Sponsor
- UMC Utrecht
Coronary Artery Disease
Balloon Elution and Late Loss Optimization (BELLO) Study
Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms: 1.
- Trial name
- BELLO (NCT01086579)
- Testing
- IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon), Taxus (Paclitaxel eluting stent)
- Where
- Italy
- Volunteers
- 182 people
- Sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
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
Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions
The purpose of this study is to investigate the long term efficacy and safety of firebird sirolimus-eluting stent for treatment of complex coronary Lesions.
- Trial name
- FIREMAN (NCT00552656)
- Testing
- Firebird(TM) Sirolimus-Eluting Stent
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xijing Hospital
Coronary Disease
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease
The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.
- Trial name
- LEFT-MAIN-2 (NCT00598637)
- Testing
- Everolimus-eluting stent (Xience), Zotarolimus-eluting stent (Endeavor Resolute)
- Where
- 4 sites in Germany, Italy
- Volunteers
- 650 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients.
- Trial name
- GERSHWIN (NCT00627900)
- Testing
- bare metal stent, Cypher-Stent (Implantation of a sirolimus-eluting stent)
- Where
- Germany
- Volunteers
- 958 people, healthy volunteers welcome
- Sponsor
- Charite University, Berlin, Germany
Vascular Diseases
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
- Trial name
- NCT05296031
- Testing
- Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions, Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Volunteers
- 49 people
- Sponsor
- Skane University Hospital
Thrombosis
Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel
A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or…
- Trial name
- NCT02140801
- Testing
- Ticagrelor, Clopidogrel
- Where
- China
- Volunteers
- 352 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Peripheral Arterial Disease
Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion.
- Trial name
- NCT07122167
- Testing
- Peripheral Drug-eluting Stent System
- Where
- Poland
- Volunteers
- 153 people
- Sponsor
- MDCECRO LLC
Instent Restenosis
The Valentines Trial
The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up.
- Trial name
- NCT01066832
- Testing
- Paclitaxel
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 276 people
- Sponsor
- Eurocor GmbH
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
In Stent Restenosis
DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is…
- Trial name
- DEB-DRAGON (NCT04415216)
- Testing
- percutaneous coronary intervention
- Where
- 9 sites in Poland
- Volunteers
- 1,369 people
- Sponsor
- Medical University of Silesia
Ischemic Heart Disease
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment.
- Trial name
- J-REVERSE (NCT01266239)
- Testing
- kissing balloon inflation, EES vs. SES
- Where
- 5 sites in Japan
- Volunteers
- 300 people
- Sponsor
- Shin Yukuhashi Hospital
Coronary Artery Disease, Atherosclerosis
Biological Efficacy of Clopidogrel After Implantation of Drug-eluting Stents (SPACE)
The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS).
- Conditions
- Coronary Artery Disease, Atherosclerosis, Diabetes Mellitus, Metabolic Syndrome X
- Trial name
- SPACE (NCT00298428)
- Testing
- blood samples
- Where
- 2 sites in France
- Volunteers
- 159 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Coronary Artery Disease
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
Objectives: 1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets. 2.
- Trial name
- NCT01605721
- Testing
- XIENCE PRIMETM everolimus-eluting coronary stent
- Where
- South Korea
- Volunteers
- 2,000 people
- Sponsor
- Seoul National University Hospital