Clinical trials: Drug Eluting Stents
In-stent Restenosis
DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
- Trial name
- NCT01127958
- Testing
- PCI with a drug-eluting balloon, PCI with a drug-eluting stent
- Where
- 8 sites in Netherlands
- Volunteers
- 270 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
De Novo Stenosis, Coronary Artery Disease
Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections.
- Trial name
- NCT04561739
- Testing
- Paclitaxel coated balloon, Sirolimus eluting stents
- Where
- China
- Volunteers
- 2,272 people
- Sponsor
- Xijing Hospital
Coronary Artery Disease, Percutaneous Coronary Intervention
Xience Registry In Complex Lesion of Acute Coronary Syndrome Patients witH Ticagrelor (RICH)
The goal of this multicenter prospective clinical cohort study is to investigate the impact of early use of low-dose Ticagrelor-based dual antiplatelet agent therapy (TDAPT) (ticagrelor 120mg daily; l-TDAPT) as compared to…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- Trial name
- RICH (NCT05746416)
- Where
- South Korea
- Volunteers
- 977 people
- Sponsor
- Hanyang University Seoul Hospital
Coronary Artery Disease, Angina Pectoris
Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents
Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of…
- Conditions
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
- Trial name
- NCT01443104
- Testing
- Sirolimus-eluting stent with a bioresorbable polymer (Orsiro), Everolimus-eluting stent with a durable polymer
- Where
- 9 sites in Switzerland
- Volunteers
- 2,119 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
ST-elevation Myocardial Infarction
Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction (STEMI)
Stent study: Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is effective but there remain concerns regarding the long-term safety and adverse effects on the adjacent arterial wall.
- Trial name
- COMFORTABLE (NCT00962416)
- Testing
- Biolimus eluted from an erodable stent coating (Biomatrix), bare-metal stent (Gazelle)
- Where
- 5 sites in Switzerland
- Volunteers
- 1,161 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
In-Stent Restenosis
P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameters between 2.5 mm and 3.5 mm and ≤ 22 mm…
- Trial name
- NCT00393315
- Testing
- paclitaxel coated balloon catheter
- Where
- 10 sites in Germany
- Volunteers
- 120 people
- Sponsor
- University Hospital, Saarland
Coronary Heart Disease
Prospective Assessment of Efficacy and Safety of Drug Eluting Stents
Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the…
- Trial name
- PEACE-DES (NCT02313038)
- Where
- China
- Volunteers
- 6,023 people
- Sponsor
- China National Center for Cardiovascular Diseases
Restenosis
Treatment of Coronary In-Stent Restenosis
The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.
- Trial name
- TIS (NCT01735825)
- Testing
- paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus, seal-wing paclitaxel-eluting balloon catheter
- Where
- Czechia
- Volunteers
- 199 people
- Sponsor
- University Hospital Ostrava
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.
Coronary Artery Disease, Antiplatelet Drugs
IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and…
- Trial name
- OPTION2 (NCT06451198)
- Testing
- Indobufen, Aspirin, Ticagrelor
- Where
- China
- Volunteers
- 2,846 people
- Sponsor
- Shanghai Zhongshan Hospital
In-stent Coronary Artery Restenosis
In-stent Restenosis in Patients With Patent Previous Bare Metal Stent
Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis within previously deployed stent, is most…
- Trial name
- NCT01296399
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Rambam Health Care Campus
Coronary Artery Disease, Drug Eluting Stent
CREATE Trial, Prospective, Observational Study
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
- Trial name
- NCT05658250
- Testing
- CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
- Where
- South Korea
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Coronary Artery Disease
Long Term Outcomes Of Hybrid Percutaneous Approach
Bioresorbable vascular scaffolds (BVS) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up.
- Trial name
- NCT03570762
- Testing
- hybrid percutaneous intervention
- Volunteers
- 40 people
- Sponsor
- Liv Hospital Ankara
Coronary Heart Disease
3 Limus Agent Eluting Stents With Different Polymer Coating
The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at…
- Trial name
- ISAR-TEST-4 (NCT00598676)
- Testing
- biodegradable polymer Rapamycin-eluting stent, permanent polymer rapamycin-eluting stent (Cypher), permanent polymer everolimus-eluting stent (Xience, Promus)
- Where
- 2 sites in Germany
- Volunteers
- 2,600 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus…
- Trial name
- INSTANT (NCT01454440)
- Testing
- Eptifibatide
- Where
- Italy
- Volunteers
- 91 people
- Sponsor
- University of Turin, Italy
Peripheral Vascular Disease
The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery for the Treatment The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery of Femoropopliteal TASC C&D Lesions
The objective of this clinical investigation is to evaluate the early and mid-term outcome (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX paclitaxel-eluting stent (Cook) versus bypass…
- Trial name
- ZILVERPASS (NCT01952457)
- Testing
- Zilver PTX, prosthetic bypass
- Where
- 5 sites in Belgium
- Volunteers
- 220 people
- Sponsor
- Flanders Medical Research Program
Coronary Artery Disease
1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials
Prospective, multicenter, randomized, double-blind, placebo-controlled trials.
- Trial name
- NCT03971500
- Testing
- AntiPlatelet therapy, Percutaneous coronary intervention
- Where
- China
- Volunteers
- 3,710 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University