Clinical trials: In-Stent Restenosis, open to volunteers
Femoropopliteal In-Stent Restenosis (ISR)
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment.
- Trial name
- NCT07277218
- Testing
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Where
- 10 sites in China
- Volunteers
- 600 people
- Sponsor
- Chunshui He
Intracranial Atherosclerotic Disease (ICAD), Intracranial Arterial Stenosis
Photon-counting CT for Intracranial Stent Assessment
Intracranial atherosclerotic disease is an important cause of ischemic stroke, and intracranial stent implantation is increasingly used for patients with severe stenotic lesions.
- Conditions
- Intracranial Atherosclerotic Disease (ICAD), Intracranial Arterial Stenosis, Stent Restenosis, Ischemic Stroke
- Trial name
- NCT07769814
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xin Lou
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
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
PCI, In-stent Restenosis
Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR
This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.
- Conditions
- PCI, In-stent Restenosis, Intravascular Imaging Device
- Trial name
- NCT07297641
- Testing
- percutaneous coronary intervention
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
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.
Stent Restenosis
Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting
Intrastent restenosis is a common complication after intracranial and extracranial arterial stenting and an important cause of recurrent ischemic stroke.
- Trial name
- NCT06112028
- Testing
- Tongxinluo capsule, Primary therapy
- Volunteers
- 200 people
- Sponsor
- Yanbin Li
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
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions.
- Conditions
- Chronic Venous Disease, Chronic Venous Insufficiency, CVI, Venous Thrombosis, Thrombosis (Stent Thrombosis)
- Trial name
- CALIBER (NCT07529756)
- Testing
- Recanalization and debulking
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Intervene, Inc.