Clinical trials: Ischemic Lesions
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
Stenosis, Occlusion
Local Paclitaxel or Balloon Angioplasty Below the Knee
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SAMBA (NCT03149913)
- Testing
- SequentPlease OTW paclitaxel coated balloon catheter, conventional uncoated balloon for BTK endovascular therapy
- Where
- 7 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Prof. Dr. med. Gunnar Tepe
Coronary Artery Disease
Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
The purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs.
- Trial name
- AR-PCI (NCT03531424)
- Testing
- Angiographic guided PCI, Augmented-Reality CTA guided PCI
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Paul Knaapen
Coronary Artery Disease (CAD)
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary…
- Trial name
- TRAD-PREP (NCT07899021)
- Testing
- TRADENT Scoring Balloon, Conventional Non-Scoring Coronary Balloon
- Volunteers
- 580 people
- Sponsor
- Ulsan University Hospital
Atherosclerosis, Coronary Artery Disease
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery…
- Trial name
- PTChina (NCT01285999)
- Testing
- PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent System
- Where
- 15 sites in China
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Angina (Stable), CAD - Coronary Artery Disease
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2.
- Conditions
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- ADVANCE-DUO (NCT07368933)
- Testing
- SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Advanced NanoTherapies
Coronary Artery Disease
WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis.
- Trial name
- WEDGES (NCT05019443)
- Testing
- Wedge Scoring Balloon, Conventional Balloon
- Where
- 5 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Stephane Carlier
Coronary Artery Disease, Myocardial Infarction
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined…
- Trial name
- ROLLING-STONE (NCT05016726)
- Testing
- Intravascular Lithotripsy
- Volunteers
- 400 people
- Sponsor
- SS Annunziata Hospital, Savigliano
Coronary Artery Disease, Drug-eluting Stents
Safety and Efficacy of the Ultimaster Stent
Durable polymer was considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis.
- Trial name
- NCT05677711
- Testing
- ultimaster
- Where
- South Korea
- Volunteers
- 204 people
- Sponsor
- Yonsei University
Dissection, Aortic
sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery
Type A acute aortic dissection (TAAAD) is a life-threatening disease that typically requires emergency surgery to prevent rupture from causing major bleeding events, with insufficient attention paid to its thromboembolic events.
- Trial name
- NCT07750548
- Testing
- sirA-CPB strategy, the traditional CPB strategy
- Volunteers
- 270 people
- Sponsor
- Xiangya Hospital of Central South University
Coronary Artery Disease
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary…
- Trial name
- NCT00192881
- Testing
- Bx Sonic & Cypher stent from Cordis
- Where
- Denmark
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Coronary Artery Disease
Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions
The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting…
- Trial name
- 3D (NCT00233714)
- Testing
- CYPHER Sirolimus-Eluting Coronary Stent
- Where
- Brazil
- Volunteers
- 56 people
- Sponsor
- Cordis US Corp.
Lower Limb Ischemia, Peripheral Arterial Disease
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
- Conditions
- Lower Limb Ischemia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Chronic Limb Ischemia
- Trial name
- SupPORT regist (NCT06416644)
- Testing
- Supera Vasculomimetic Stent
- Where
- 15 sites in Portugal
- Volunteers
- 100 people
- Sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Myocardial Ischemia
Multimodality Investigation of Intermediate Culprit Lesion With Negative FFR in NSTE-ACS
Ten-fifteen percent of acute coronary syndromes without ST-segment elevation (NSTE-ACS) are caused by intermediate lesions without signs of unstable plaque.
- Trial name
- SHERLOCK (NCT03205514)
- Testing
- NSTE-ACS with intermediate stenosis and negative FFR
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- University Hospital of Ferrara
Coronary Artery Disease
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting…
- Trial name
- DEBSCAN-IVL (NCT06657833)
- Testing
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon, Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
- Where
- 15 sites in Netherlands, Spain
- Volunteers
- 128 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx…
- Trial name
- NCT00232765
- Testing
- CYPHER Sirolimus-Eluting Stent, Uncoated BX VELOCITY Balloon-Expandable Stent
- Where
- United States
- Volunteers
- 1,058 people
- Sponsor
- Cordis US Corp.
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
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit