Clinical trials: Coronary Artery In-stent Restenosis, open to volunteers
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
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 In-stent Restenosis, Coronary Artery Disease
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
This prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent…
- Trial name
- SPRIT (NCT07920055)
- Testing
- SeQuent SCB sirolimus-coated balloon, RESTORE DEB paclitaxel-coated balloon
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Sir Run Run Shaw Hospital
Coronary Artery Disease, In-stent Restenosis
Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study
The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).
- Trial name
- SFRGENISTA (NCT06104007)
- Testing
- Genoss® DCB
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Seoul National University Hospital
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.
In-Stent Restenosis, Cardiovascular Diseases
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
- Conditions
- In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- MAGICAL ISR (NCT05908331)
- Testing
- Sirolimus Drug Coated Balloon, Plan balloon Angioplasty (POBA)
- Where
- 28 sites in United States
- Volunteers
- 492 people
- Sponsor
- Concept Medical Inc.
In-Stent Restenosis or De Novo Coronary Artery Lesions
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system.
- Trial name
- NCT07415902
- Testing
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Where
- China
- Volunteers
- 252 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Coronary Angioplasty, Restenosis
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis.
- Conditions
- Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent
- Trial name
- OSCAR (NCT07316504)
- Testing
- Intravascular lithotripsy, Balloon
- Where
- 2 sites in France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Clermont-Ferrand
Coronary Artery Disease, Stent Restenosis
Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis
Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists.
- Conditions
- Coronary Artery Disease, Stent Restenosis, STENT
- Trial name
- INSIDE OCT (NCT06779110)
- Testing
- Percutaneous Coronary Intervention
- Where
- 12 sites in Italy
- Volunteers
- 360 people
- Sponsor
- San Luigi Gonzaga Hospital
Coronary Artery Disease
SONICURE（SONICracker for the Treatment of UndeRExpansion）
The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery.
- Trial name
- NCT06924736
- Testing
- Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter, Non - compliant balloon dilatation catheter
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Coronary Artery Disease, Arteritis
National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
This project aims to establish a clinical cohort and diagnostic assessment framework by conducting a national multicenter cohort registry study.
- Conditions
- Coronary Artery Disease, Arteritis, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- RECUR Registry (NCT05437965)
- Testing
- Treatment made by experienced clinicians
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
In-stent Restenosis Lesion, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Sirolimus With corTicOsteroid TheraPy for Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
This study aims to evaluate, through a multicenter, prospective, double-blind, randomized, placebo-controlled clinical trial, whether immunosuppressive therapy improves target lesion-related cardiovascular outcomes compared to…
- Trial name
- STOP-RECUR (NCT06981845)
- Testing
- Immunosuppressive therapy
- Volunteers
- 52 people
- Sponsor
- China National Center for Cardiovascular Diseases
Coronary Artery Disease
Virtue® SAB in the Treatment of Coronary ISR Trial
A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the…
- Trial name
- NCT07045194
- Testing
- Virtue Sirolimus AngioInfusion Balloon, AGENT™ Paclitaxel Drug-Coated Balloon
- Where
- 22 sites in United States
- Volunteers
- 740 people
- Sponsor
- Orchestra BioMed, Inc
Coronary Artery Disease, Restenoses, Coronary
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting…
- Trial name
- ISAR-DESIRE5 (NCT05544864)
- Testing
- Drug eluting stent (DES), Drug coated ballloon (DCB)
- Where
- 5 sites in Germany, Spain
- Volunteers
- 376 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Arterial Disease (CAD), In Stent Restenosis
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
- Conditions
- Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions
- Trial name
- OPEN-SAFE (NCT07646444)
- Testing
- non compliant balloon
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Minneapolis Heart Institute Foundation
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
The Real-World Drug-Coated Balloon Registry (RW-DCB) is an investigator-initiated, multicenter, observational cohort study evaluating the use of drug-coated balloons (DCBs) during percutaneous coronary intervention (PCI) in…
- Trial name
- RW-DCB (NCT07875088)
- Testing
- Coronary Drug-Coated Balloon
- Where
- 5 sites in Mexico, Spain
- Volunteers
- 2,000 people
- Sponsor
- Kristian Rivera
Coronary Artery Disease, Coronary Disease
Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).
- Conditions
- Coronary Artery Disease, Coronary Disease, PCI, Stent Restenosis
- Trial name
- ACDC (NCT06499207)
- Testing
- Photon-counting detector computed tomography (PCD-CT)
- Volunteers
- 25 people
- Sponsor
- Medical University of Vienna
Coronary Arterial Disease (CAD)
The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent…
- Trial name
- NCT07159087
- Testing
- Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Genoss Co., Ltd.