Clinical trials: Ischemic Lesions, open to volunteers
Coronary Artery Disease, Ischemic Heart Disease
LONG NAGOMI™ PMCF STUDY
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ _stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according…
- Trial name
- LONG NAGOMI (NCT07399002)
- Testing
- LONG NAGOMI
- Where
- 10 sites in Spain
- Volunteers
- 1,039 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease (non-left Main), Coronary Bifurcation Lesion
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice.
- Trial name
- EBC DCB (NCT06822322)
- Testing
- Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy, Drug Coated Balloon Strategy
- Volunteers
- 750 people
- Sponsor
- Ceric Sàrl
Acute Coronary Syndrome
Thrombus Aspiration and Pathology and OCT Study
Most acute coronary syndromes (ACS) are caused by plaque complications triggering thrombotic events in the culprit plaques. Plaque complications include plaque rupture (Ruptured Fibrous Cap-RFC) with exposure of highly…
- Trial name
- TAPOS (NCT07151976)
- Testing
- PCI
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Fujita Health University
Coronary Heart Disease
Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )
Since Gruntzig successfully performed percutaneous coronary balloon angioplasty in 1977, percutaneous coronary intervention has developed rapidly.
- Trial name
- NCT04104854
- Testing
- drug coated balloon
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Cardiogenic Shock, Acute Myocardial Infarction
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and…
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Decompensated Heart Failure
- Trial name
- NCT07825363
- Testing
- NIRSense Tissue Oximetry Sensor System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NIRSense Inc.
Ischemic Stroke
A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke
This Phase 3 study will evaluate whether lesion network mapping-guided continuous theta burst stimulation (cTBS) can improve recovery after acute ischemic stroke.
- Trial name
- MASTRE-3 (NCT07645586)
- Testing
- LNM-navigated cTBS
- Where
- China
- Volunteers
- 584 people
- Sponsor
- Beijing Tiantan Hospital
Coronary Disease, Coronary Artery Disease
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization.
- Conditions
- Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis
- Trial name
- VICTORY (NCT05346068)
- Testing
- OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
- Where
- Switzerland
- Volunteers
- 280 people
- Sponsor
- Luzerner Kantonsspital
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
In-Stent Coronary Artery Restenosis, Coronary Artery Disease
The PICCOLETO XI A-PREP Study
To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).
- Trial name
- PICCOLETO-XI (NCT07391033)
- Volunteers
- 500 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
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 Arterial Disease (CAD)
Drug-Coated Coronary Balloons in Different Clinical Scenarios
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions.
- Trial name
- DCB-DCS (NCT06915597)
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 1,500 people
- Sponsor
- Kutahya Health Sciences University
Coronary Artery Calcification, Ischemic Heart Disease
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation.
- Conditions
- Coronary Artery Calcification, Ischemic Heart Disease, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Coronary Artery Disease
- Trial name
- NCT06507449
- Testing
- Lithotripsy, Orbital atherectomy, High-pressure non-compliant balloon
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Medical University of Silesia
Coronary Artery Disease, Coronary Stenosis
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Coronary Disease
- Trial name
- T-REX (NCT05782738)
- Testing
- Percutaneous Coronary Intervention
- Where
- 5 sites in Italy
- Volunteers
- 361 people
- Sponsor
- San Luigi Gonzaga Hospital
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
Coronary Disease, Heart Diseases
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- BIOMAG-III (NCT07258290)
- Testing
- Freesolve RMS, Xience DES
- Where
- 3 sites in United States, Latvia
- Volunteers
- 1,859 people
- Sponsor
- Teleflex
Coronary Artery Disease, Ischemic Heart Disease
Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation…
- Trial name
- PROVISIONDEB (NCT06002932)
- Testing
- Procedure: planed 2-stent strategy, Procedure: provisional 1-stent plus DEB strategy
- Where
- South Korea
- Volunteers
- 750 people
- Sponsor
- Saint Vincent's Hospital, Korea
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.
Coronary Artery Disease, OCT Angiography
Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques
This study evaluates the diagnostic accuracy and limitations of photon-counting computed tomography (PCCT) in characterizing coronary plaque, with comparisons to optical coherence tomography (OCT) and intravascular ultrasound…
- Conditions
- Coronary Artery Disease, OCT Angiography, CT
- Trial name
- C-EAGLE (NCT07036770)
- Testing
- Coronary CT scan using photon-counting CT
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Coronary Artery Disease, Chronic Renal Failure
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
- Trial name
- CRATER (NCT05353946)
- Testing
- Percutaneous coronary intervention (PCI)
- Where
- Spain
- Volunteers
- 124 people
- Sponsor
- Guillermo Galeote; MD, PhD
Diabetes Mellitus, Coronary Arterial Disease (CAD)
Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus
Purpose of this study: The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own.
- Conditions
- Diabetes Mellitus, Coronary Arterial Disease (CAD), de Novo Coronary Lesions, De Novo Stenosis
- Trial name
- DUBSTENT-DM (NCT07303439)
- Testing
- Percutaneous Coronary Intervention
- Where
- Ireland
- Volunteers
- 120 people
- Sponsor
- Royal College of Surgeons, Ireland