Clinical trials: Complex Coronary Lesions
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
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
An Assessment of the Glider Balloon in Complex Lesions
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into…
- Trial name
- ANTELOPE (NCT02396186)
- Testing
- PTCA Balloon Angioplasty
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- TriReme Medical, LLC
Complex Coronary Lesions
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or…
- Trial name
- IVUS-CHIP (NCT04854070)
- Testing
- IVUS, Angio
- Where
- 37 sites in Belgium, France and 5 more
- Volunteers
- 2,020 people
- Sponsor
- ECRI bv
Coronary Artery Stenosis
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions.
- Trial name
- COBRA (NCT00895791)
- Testing
- AXXESS Biolimus A9-eluting bifurcation stent, culotte stenting (Xience V)
- Where
- Belgium
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Cardiovascular Diseases, Coronary Artery Disease
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery…
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- Trial name
- ASSURE ROT (NCT01915420)
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
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 Artery Disease, Atherosclerosis
Drug-eluting Balloon in Bifurcations Trial
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina
- Trial name
- DEBIUT (NCT00857441)
- Testing
- Drug eluting balloon, Liberté, PTCA balloon catheter
- Where
- 3 sites in Belgium, Netherlands
- Volunteers
- 120 people
- Sponsor
- UMC Utrecht
Left Main Coronary Artery Disease
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques.
- Trial name
- NCT06546748
- Where
- Turkey (Türkiye)
- Volunteers
- 531 people, healthy volunteers welcome
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Coronary Artery Disease (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Atrial Fibrillation, Recurrence
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear…
- Trial name
- ADLINE (NCT02059369)
- Testing
- PVI+CFAE+DCC, PVI, CFAE, anterior and roof line, DCC
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease
Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous…
- Trial name
- ATTEMPT (NCT04014803)
- Testing
- Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
- Where
- 2 sites in South Korea
- Volunteers
- 3,500 people
- Sponsor
- Samsung Medical Center
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 (CAD), Percutaneous Coronary Intervention (PCI)
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy.
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- Trial name
- NCT07849335
- Testing
- Percutaneous Coronary Intervention with Minicrush
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- San Luigi Gonzaga 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
Calcific Coronary Arteriosclerosis
Prospective Registry on Intravascular Lithotripsy
multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.
- Trial name
- BENELUX-IVL (NCT06577038)
- Testing
- PCI with use of IVL
- Where
- 8 sites in Belgium, Greece and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Leiden University Medical Center
Myocardial Infarction
Angiography Versus (vs) IVUS Optimisation
The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions
- Trial name
- AVIO (NCT00936169)
- Testing
- IVUS optimised DES implantation, angiographically guided DES implantation
- Volunteers
- 284 people
- Sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Arrhythmias, Cardiac, Bradycardia
Analysis of the Efficacy and Stability of a Wearable ECG Monitor
This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a…
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation
- Trial name
- NCT06546046
- Testing
- ECG monitoring by telemetry device and patch-type ECG monitor at the same time
- Volunteers
- 100 people
- Sponsor
- Mezoo Co., Ltd.
Complex Coronary Lesions, Percutaneous Coronary Intervention
Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications…
- Trial name
- ULTRACOLOR (NCT04837404)
- Testing
- Ultrasound guided femoral access for complex PCI, Fluoroscopy guided femoral access for complex PCI
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 544 people
- Sponsor
- Maatschap Cardiologie Zwolle
Complex Calcified Coronary Lesions
Rotational Atherectomy Prior to Taxus Stent
The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined…
- Trial name
- NCT00380809
- Testing
- Rotational Atherectomy + PES, Standard Treatment (PES without Rotational Atherectomy)
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- Segeberger Kliniken GmbH