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In-Stent Restenosis clinical trials

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NCT ID: NCT06104007 Recruiting - Clinical trials for Coronary Artery Disease

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

SFRGENISTA
Start date: August 17, 2023
Phase:
Study type: Observational

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).

NCT ID: NCT05908331 Recruiting - Clinical trials for Coronary Artery Disease

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

MAGICAL ISR
Start date: April 16, 2024
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouchâ„¢ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouchâ„¢ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouchâ„¢ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

NCT ID: NCT05656118 Recruiting - In-stent Restenosis Clinical Trials

Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)

GENISPIRE
Start date: August 31, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients. The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.

NCT ID: NCT05623995 Recruiting - In-stent Restenosis Clinical Trials

Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)

Start date: December 15, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).

NCT ID: NCT05473884 Recruiting - In-stent Restenosis Clinical Trials

Lesion Preparation in Femoropopliteal Artery Occlusion Disease

CIVILIAN
Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.

NCT ID: NCT04220437 Recruiting - In-stent Restenosis Clinical Trials

Identification of Neoatherosclerosis in ISR Patients Based on Artifical Intelligence

Start date: February 1, 2015
Phase:
Study type: Observational

Based on the large population of patients, in-stent restenosis (ISR) is still an important problem in the field of cardiovascular disease. How to reduce the incidence of ISR and the treatment of ISR has become the focus and hot spot. The 2018 ESC Guidelines for Cardiovascular Intervention recommends treatment of ISR under the guidance of intravascular ultrasound (IVUS), or optical coherent tomography (OCT). Circulation published a new Waksman ISR classification based on mechanisms and components of the restenosis tissue, which provides guidance for treatment strategy. Because of its good resolution, OCT makes it more accurate to distinguish the components of vascular tissue, thus providing a decision-making basis for interventional therapy. OCT examination can obtain the characteristics of the ISR more precisely. Neoatherosclerosis (NA), is one of the ISR types and accounts for more stent failure and target lesion failure than other types. Identification NA is important for decision-making of interventional therapy. However, the acquisition and analysis of OCT images not only need the digital angiography machine (DSA) equipped with the majority of hospitals, but also need professional OCT imaging equipment and technicians. Patients with severely CKD cannot bear OCT examination because of the large amount of contrast agent. OCT catheter is more than ten times the price of the CAG catheter. Therefore, identification of NA by the use of artificial intelligence (AI) is of significance to set therapeutic strategy for ISR patients, especially in patients with CKD. Our study retrospectively analyzed CAG images and OCT images of ISR patients obtained from Jan 1st,2015 to Oct 31st,2020. Identify NA by analyzing OCT images, build up U-net and V-net to analyze the CAG and OCT images, and finally build up an identification system of NA based on CAG images by AI. This study has been approved by Ethics Committee of Chinese PLA General Hospital (S2018-033-01)

NCT ID: NCT03874481 Recruiting - Clinical trials for Coronary Artery Disease

The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis

Start date: November 1, 2018
Phase:
Study type: Observational

This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

NCT ID: NCT03521843 Recruiting - Clinical trials for Peripheral Artery Disease

LDD in Treatment of Femoropopliteal ISR

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

NCT ID: NCT02891018 Recruiting - In-stent Restenosis Clinical Trials

Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter

Start date: December 2015
Phase: Phase 3
Study type: Interventional

Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis. Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please

NCT ID: NCT01255956 Recruiting - In-Stent Restenosis Clinical Trials

Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)

ISRII
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.