Clinical trials: Restenotic Coronary Lesions
Coronary Artery Disease
The Medtronic RESOLUTE US Clinical Trial
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter…
- Trial name
- R-US (NCT00726453)
- Testing
- Resolute Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 1,516 people
- Sponsor
- Medtronic Vascular
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 study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-V (NCT02389946)
- Testing
- Orsiro DES, Xience DES
- Where
- 92 sites in United States, Australia and 11 more
- Volunteers
- 1,334 people
- Sponsor
- Biotronik, Inc.
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.
PCI Patients, de Novo Coronary Lesions
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
Prospective, multi-center, all comers, post market clinical follow-up (PMCF) registry.
- Conditions
- PCI Patients, de Novo Coronary Lesions, Restenotic Coronary Lesions, Acute Myocardial Infarction (AMI)
- Trial name
- iLITE (NCT07887230)
- Testing
- Percutaneous Coronary Intervention
- Volunteers
- 5,000 people
- Sponsor
- iVascular S.L.U.
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE China RCT
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- R-China RCT (NCT01334268)
- Testing
- Taxus Liberte Paclitaxel-Eluting Coronary Stent System, Resolute Zotarolimus-Eluting Coronary Stent System
- Where
- 4 sites in China
- Volunteers
- 400 people
- Sponsor
- Medtronic Vascular
Coronary Arteries Disease
BIOHELIX-I Bare Metal Stent Study
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
- Trial name
- BIOHELIX-I (NCT01612767)
- Testing
- PRO-Kinetic Energy Stent
- Where
- 35 sites in United States, Colombia and 3 more
- Volunteers
- 329 people
- Sponsor
- Biotronik, Inc.
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE China Registry:
To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- R-C Registry (NCT01243749)
- Where
- 6 sites in China
- Volunteers
- 1,800 people
- Sponsor
- Medtronic Vascular
Myocardial Infarction, Drug-Coated Balloon
Prevail Drug Balloon Study
This is an investigator-initiated, prospective, single-centre, non-randomized, all-comers registry that evaluates the safety and efficacy of any Paclitaxel Drug-Coated Balloon (DCB) for the treatment of coronary de novo lesion…
- Trial name
- NCT05562089
- Testing
- A Paclitaxel Drug-Coated Balloon
- Where
- Hong Kong
- Volunteers
- 50 people
- Sponsor
- Chinese University of Hong Kong
Coronary Stenosis, Drug-coated Balloon
DCB Angioplasty for Coronary Lesions: an OCT Analysis
In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization.
- Trial name
- NCT04984135
- Testing
- Percutaneous coronary intervention
- Where
- China
- Volunteers
- 70 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Coronary Artery Disease
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent
This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS.
- Trial name
- NCT00233792
- Testing
- sirolimus coated Bx VELOCITY stent - fast release, sirolimus coated Bx VELOCITY stent - slow release
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- Cordis US Corp.
In-Stent Restenosis
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery…
- Trial name
- NCT00231257
- Testing
- Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent, Brachytherapy
- Where
- United States
- Volunteers
- 384 people
- Sponsor
- Cordis US Corp.
Arterial Occlusive Diseases, Myocardial Ischemia
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
- Conditions
- Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- RJ (NCT00927940)
- Testing
- MDT-4107 Drug Eluting Stent
- Where
- 14 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
- Trial name
- TROPICAL (NCT00232856)
- Testing
- drug-eluting stent
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 162 people
- Sponsor
- Cordis US Corp.
Ischemic Heart Disease, Coronary Stenosis
RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia
The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring…
- Conditions
- Ischemic Heart Disease, Coronary Stenosis, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- R-A (NCT01132456)
- Testing
- Drug eluting stent treatment
- Where
- India
- Volunteers
- 312 people
- Sponsor
- Medtronic Vascular