Clinical trials: Stenotic Coronary Lesion
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China RCT Study
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03466151
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 550 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease, Coronary Disease
The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.
- Conditions
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Trial name
- NCT05904951
- Testing
- INVADER™ PTCA Balloon Dilatation Catheter
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Alvimedica
Chronic Total Occlusion, Atherosclerosis
Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)
The purpose of this registry study is to gather real world standard of care (SOC) data on the safety and performance on the Roxwood Medical catheter devices in the treatment of stenotic lesions and CTO.
- Conditions
- Chronic Total Occlusion, Atherosclerosis, Coronary Artery Disease, Peripheral Artery Disease
- Trial name
- NCT04059536
- Testing
- Roxwood Anchoring Catheters, Acetylsalicylic Acid, Heparin
- Where
- 11 sites in United States
- Sponsor
- Boston Scientific Corporation
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
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
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
Coronary Arteriosclerosis
Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions
To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native…
- Trial name
- RECOVERY (NCT02542007)
- Testing
- OrbusNeich Combo stent™, sirolimus-eluting stent system
- Where
- 15 sites in China
- Volunteers
- 440 people
- Sponsor
- OrbusNeich
Ischemic Heart Disease, Stenotic Coronary Lesion
China Resolute Integrity 34/38 mm Study
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03118531
- Testing
- Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Medtronic Vascular
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
Coronary Arterial Disease
Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device
The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy…
- Trial name
- FORWARD IVL (NCT07109479)
- Testing
- Intravascular Lithotripsy, Rotational Atherectomy
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
de Novo Stenotic Lesions in Native Coronary Arteries
NIRTRAKS Post-Market Study (NIRTRAKS)
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US).
- Trial name
- NIRTRAKS (NCT02455804)
- Testing
- Stenting procedure
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medinol Ltd.
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China Single Arm Study
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03471845
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Where
- China
- Volunteers
- 591 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Stenosis
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare…
- Trial name
- BLAST (NCT00739466)
- Testing
- Liposomal Alendronate
- Where
- 12 sites in Israel
- Volunteers
- 226 people
- Sponsor
- BIOrest Ltd.
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Stenosis
De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions
The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS).
- Trial name
- NCT00934752
- Testing
- Lutonix Paclitaxel-Coated Balloon
- Where
- 3 sites in Netherlands
- Volunteers
- 24 people
- Sponsor
- C. R. Bard
De Novo and Re-stenosed Coronary Artery Lesions
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
- Trial name
- ENERGY (NCT01056120)
- Testing
- Pro Kinetic Energy bare metal stent
- Where
- 50 sites in Austria, Belgium and 8 more
- Volunteers
- 1,026 people
- Sponsor
- Biotronik AG