Clinical trials: Drug Eluting Stent
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Coronary Heart Disease
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected…
- Trial name
- PE-Prove (NCT01148329)
- Testing
- Coronary stenting
- Where
- 40 sites in Austria, Belgium and 9 more
- Volunteers
- 1,010 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Stenosis
Angiography Study of BioNIR Drug Eluting Stent System (NIREUS)
The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter…
- Trial name
- NIREUS (NCT01995500)
- Testing
- BioNIR, Resolute
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Medinol Ltd.
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis of Native Arteries of the Extremities
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
- Trial name
- MAJESTIC (NCT01820637)
- Testing
- The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
- Where
- 13 sites in Australia, Austria and 3 more
- Volunteers
- 57 people
- Sponsor
- Boston Scientific Corporation
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.
Coronary Artery Disease, Coronary Restenosis
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is…
- Trial name
- BIOLUX-RCT (NCT01651390)
- Testing
- Percutaneous coronary intervention
- Where
- 14 sites in Germany, Latvia
- Volunteers
- 231 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease Below The Knee
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK…
- Trial name
- POP-BTK (NCT05267548)
- Where
- 8 sites in Belgium
- Volunteers
- 143 people
- Sponsor
- iVascular S.L.U.
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 (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease
Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation)
The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent…
- Trial name
- DECIDE (NCT00440674)
- Testing
- CoStar Paclitaxel-eluting coronary stent system
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Conor Medsystems
Coronary Artery Disease
The Direct III Post Market Study
The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated…
- Trial name
- Direct III (NCT02693158)
- Where
- 8 sites in Netherlands
- Volunteers
- 440 people
- Sponsor
- Svelte Medical Systems, Inc.
Diabetes Mellitus
BLADE-PCI Trial (BLADE); PHASE IIB LIPOSOMAL ALENDRONATE STUDY
The main objective of this study is to assess the safety, efficacy and dose response of LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent in reducing restenosis…
- Trial name
- BLADE (NCT02645799)
- Testing
- LABR-312
- Where
- Israel
- Volunteers
- 270 people
- Sponsor
- BIOrest Ltd.
Coronary Artery Lesions
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary…
- Trial name
- NCT03218787
- Testing
- XIENCE, DAPT
- Where
- 101 sites in United States
- Volunteers
- 2,047 people
- Sponsor
- Abbott Medical Devices
Coronary Disease
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after…
- Trial name
- NCT00415961
- Testing
- CoStar Paclitaxel Drug-Eluting Coronary Stent System
- Where
- Japan
- Volunteers
- 120 people
- Sponsor
- Conor Medsystems
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
Peripheral Artery Disease
Zilver® PTX® in China
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
- Trial name
- NCT02171962
- Testing
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Where
- 9 sites in China
- Volunteers
- 178 people
- Sponsor
- Cook Group Incorporated
Coronary Disease, Coronary Artery Disease
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ZoMaxx™ II (NCT00140101)
- Testing
- ZoMaxx™ Drug-Eluting Coronary Stent System, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 92 sites in United States, Australia and 2 more
- Volunteers
- 1,099 people
- Sponsor
- Abbott Medical Devices
Coronary Arteriosclerosis, Acute Coronary Syndrome
GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.
- Trial name
- GRAVITAS (NCT00645918)
- Testing
- clopidogrel
- Where
- 82 sites in United States, Canada
- Volunteers
- 2,800 people
- Sponsor
- Accumetrics, Inc.
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