Clinical trials: In-Stent Restenosis
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length…
- Trial name
- AGENT IDE (NCT06492174)
- Testing
- AGENT DCB 40 mm
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
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
- Volunteers
- 600 people
- Sponsor
- Chunshui He
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.
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 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
In-stent Restenosis
Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)
To demonstrate acceptable short term safety rates of the Drug-eluting Coronary Spur Stent System as a primary treatment for coronary in-stent restenosis.
- Trial name
- NCT06117150
- Testing
- Drug-eluting Coronary Spur Stent System
- Where
- 2 sites in New Zealand
- Volunteers
- 9 people
- Sponsor
- ReFlow Medical, Inc.
Coronary Artery Disease, In-stent Restenosis
To Study and Explore the Predictive Effect of Insulin Resistance-related Indicators on In-stent Restenosis After Coronary Stent Implantation
Based on previous studies on insulin resistance and cardiovascular diseases, we believe that the insulin resistance metabolic score also has certain predictive value for the prognosis of in-stent restenosis after coronary stent…
- Trial name
- NCT07614763
- Testing
- Observational studies do not design intervention measures
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Qilu Hospital of Shandong University
Coronary Stent Restenosis
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).
- Trial name
- OPEN-ISR (NCT04862052)
- Testing
- Intravascular management of prior implanted coronary drug eluting stent restenosis
- Where
- 2 sites in Hungary
- Volunteers
- 108 people
- Sponsor
- Semmelweis University Heart and Vascular Center
In-stent Restenosis
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
- Trial name
- NCT05731700
- Testing
- Drug Eluting Balloon
- Where
- 9 sites in France, Georgia and 2 more
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
ST-elevation Myocardial Infarction (STEMI), In-stent Restenosis
Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)
This randomized, double-blind, controlled clinical trial will evaluate the effects of daily supplementation with functionalized bovine milk, enriched with bioactive peptides and optimized lipid profile, on coronary in-stent…
- Trial name
- SMASOEA (NCT07176104)
- Testing
- Functional Bovine Milk, Non-Functional Bovine Milk
- Where
- Italy
- Volunteers
- 140 people
- Sponsor
- Raffaele Marfella
In-Stent Restenosis, Coronary Artery Disease
VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI
This multicenter observational study investigates whether lipid and lipoprotein subfractions measured by Vertical Auto Profile (VAP) are associated with coronary in-stent restenosis after percutaneous coronary intervention (PCI).
- Trial name
- NCT07533656
- Testing
- No intervention
- Where
- China
- Volunteers
- 3,600 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Stenosis, Coronary Artery Stenosis
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- NCT05509296
- Testing
- SINOMED CBC, NSE Coronary Dilatation Catheter
- Where
- 8 sites in China
- Volunteers
- 136 people
- Sponsor
- Sino Medical Sciences Technology 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.
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
In-stent Restenosis
Target Vessel Failure After Laser Assisted Percutaneous Angioplasty Versus Balloon-based Treatment for Drug Eluting In-stent Restenosis
Stent restenosis (ISR) is an increasingly common problem; in fact, approximately 10% of coronary angioplasty procedures involve the treatment of a previously implanted stent.
- Trial name
- SONIC (NCT07382154)
- Where
- Italy
- Volunteers
- 1,260 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
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, Coronary Artery Disease Progression
Disease Characteristics of R-CAD
The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and…
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Progression, Coronary Stenosis, Coronary Restenosis
- Trial name
- NCT07239921
- Testing
- Protocol-defined Examinations and Evaluations
- Volunteers
- 52 people
- Sponsor
- Peking Union Medical College Hospital
Coronary Artery Disease, Calcified Coronary Artery Disease
Coronary Laser in Undilatable or Uncrossable Lesions
This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation <80% at burst pressure) or…
- Conditions
- Coronary Artery Disease, Calcified Coronary Artery Disease, In Stent Restenosis, Chronic Total Occlusion (CTO)
- Trial name
- LUDICO (NCT07206082)
- Testing
- Laser atherectomy
- Where
- Spain
- Volunteers
- 230 people
- Sponsor
- Hospital Universitario La Paz