Drug-coated Balloon
Conditions
Brief summary
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
Detailed description
The treatment of coronary lesions triggers processes in vessel walls with different characteristics depending on the revascularization strategy, post-traumatic healing following plain balloon angioplasty triggers vessel recoil and neointimal overgrowth, bare metal or drug eluting stent implantation results in neointimal cell proliferation, scar tissue formation, and ultimately, the generation of neoatherosclerosis Drug-coated balloons(DCBs) were presented two decades ago as an alternative to plain-balloon inflation or subsequent stent implantation in order to overcome in-stent restenosis.Recently, there has been growing evidence that DCBs can also be used off-label to treat de novo lesions in small vessels Therefore, the aim of this study is to evaluate efficacy and safety of drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions
Interventions
DEVICEAngioplasty
Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions
Sponsors
Sohag University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.
Exclusion criteria
1. Severe renal impairment ( Cr.Cl. \< 45 ml/min ). 2. Sever heart failure or liver cell failure . 3. Patients with contraindications to coronary angiography or invasive procedures. 4. Known allergy or intolerance to the medications or devices commonly used during PCI procedures. 5. Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol. 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events at 6 months | 6 months | Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding \[BARC type 3 to 5\]) at 6 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. |
Countries
Egypt
Contacts
Primary ContactImran Saber
Outcome results
None listed