Clinical trials: Ischemic Lesions
Coronary Artery Disease, Calcification
Post-Marketing Clinical Study of High-Pressure Cutting Balloon
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation.
- Trial name
- NCT07835178
- Testing
- High pressure cutting balloon, Non-cutting balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- BrosMed Medical Co., Ltd
Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent
The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control…
- Conditions
- Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary, Stents
- Trial name
- MARTIN (NCT00637104)
- Testing
- Mar-Tyn TiN coated Co-Cr Numen stent implant, Vision Co-Cr stent implant
- Where
- 7 sites in Germany, Italy and 2 more
- Volunteers
- 160 people
- Sponsor
- International Biomedical Systems S.p.A.
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Angina Pectoris, Angina, Unstable
Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study
This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions that contain lipid cores, but are not calcified or fibrotic and are located in proximity to side branches, are associated with side…
- Conditions
- Angina Pectoris, Angina, Unstable, Atherosclerosis, Coronary Artery Disease
- Trial name
- NCT00905671
- Testing
- LipiScan Coronary Imaging Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Infraredx
Coronary Artery Disease
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse…
- Trial name
- DCB-BIF (NCT04242134)
- Testing
- Drug-coating balloon
- Where
- China
- Volunteers
- 784 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Coronary Artery Disease
Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360709
- Testing
- CRE8 sirolimus-eluting stent
- Where
- China
- Volunteers
- 800 people
- Sponsor
- CID S.p.A.
Ischemic Heart Disease, Acute Coronary Syndrome
The Israeli MGuard Registry
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction
- Trial name
- NCT00922337
- Testing
- MGuard Coronary Stent system
- Where
- 2 sites in Israel
- Volunteers
- 86 people
- Sponsor
- InspireMD
Coronary Artery Disease
Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.
- Trial name
- NCT03714802
- Testing
- Szabo T-Stenting Technique, T-Stenting Technique
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai Zhongshan Hospital
Coronary Artery Disease
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.
- Trial name
- NCT00232739
- Testing
- CYPHER Sirolimus-eluting Coronary Stent
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS
Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the…
- Trial name
- COBRAII (NCT02628288)
- Testing
- Coronary Bifurcation PCI
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural…
- Conditions
- Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis, Intravascular Lithotripsy; Rotational Atherectomy; OFDI, Orbital Atherectomy
- Trial name
- OROBICA (NCT07566403)
- Testing
- Percutaneous coronary intervention with or without stent implantation
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Papa Giovanni XXIII Hospital
Peripheral Vascular Disease
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb…
- Trial name
- PADI (NCT00471289)
- Testing
- PTA with placement of paclitaxel-eluting stent, PTA
- Where
- 3 sites in Netherlands
- Volunteers
- 144 people
- Sponsor
- Netherlands Society for Interventional Radiology
Coronary Artery Disease, Coronary Atherosclerosis
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for…
- Trial name
- ELITE (NCT00715884)
- Testing
- CYPHER® ELITE™ Sirolimus-Eluting Stent System, CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Where
- United States
- Volunteers
- 678 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
GLOBAL Clinical Study
The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary…
- Trial name
- GLOBAL (NCT01738828)
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 10,000 people
- Sponsor
- Global Genomics Group, LLC
Coronary Artery Disease
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease.
- Trial name
- NCT05750771
- Testing
- DES, DCB
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Henan Institute of Cardiovascular Epidemiology
Coronary Artery Disease
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.
- Trial name
- NCT03189641
- Testing
- Cilostazol eluting stent system (CES-1)
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- JIMRO Co., Ltd.
Angina, Stable, Angina, Unstable
Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).
The purpose of the study is to identify proteins, metabolites and signal pathways related directly to symptomatic atherosclerosis and to disease progression.
- Conditions
- Angina, Stable, Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-segment Elevation Myocardial Infarction (STEMI)
- Trial name
- NCT05319366
- Where
- 2 sites in Denmark
- Volunteers
- 225 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Peripheral Arterial Disease
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT07472439)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Volunteers
- 50 people
- Sponsor
- Angiodynamics, Inc.
Coronary Artery Disease, De Novo Stenosis Lesion
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population.
- Conditions
- Coronary Artery Disease, De Novo Stenosis Lesion, Coronary Stent Implantation
- Trial name
- ADVANCE (NCT07912541)
- Testing
- ADVA ACE Everolimus Eluting Coronary Stent System
- Volunteers
- 110 people
- Sponsor
- Advanced MedTech Solutions Pvt. Ltd.