Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340373
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
Sponsor:
National Institute of Cardiovascular Diseases Bangladesh
Organization:
National Institute of Cardiovascular Diseases Bangladesh
Study Overview
Official Title:
Clinical Angiographic Outcomes of Drug-coated Balloon Angioplasty After Successful Revascularization of Native Coronary Lesions
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The progression of cardiac revascularization techniques starting with standard balloon angioplasty POBA and progressing to the creation of drug-coated balloons DCB and drug-eluting stents DES The studys justification is presented with a focus on the significance of comprehending the clinical and angiographic outcomes of DCB angioplasty especially when considering the Bangladeshi population
This studys main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized A few specific goals are to evaluate angiographic results like percentage diameter stenosis vascular remodelling restenosis and thrombosis after DCB angioplasty and to assess clinical outcomes like worsening angina target vessel MI ischemia-driven TLR and cardiac mortality
This observational study will take place from January to December 2024 at the Department of Cardiology National Institute of Cardiovascular Diseases The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before The study includes non-randomized purposive sampling and the sample size will be determined by drawing on previous studies
Every patient will receive a thorough clinical assessment that includes a history physical examination electrocardiogram and biochemical testing The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography
The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations
This studys main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized A few specific goals are to evaluate angiographic results like percentage diameter stenosis vascular remodelling restenosis and thrombosis after DCB angioplasty and to assess clinical outcomes like worsening angina target vessel MI ischemia-driven TLR and cardiac mortality
This observational study will take place from January to December 2024 at the Department of Cardiology National Institute of Cardiovascular Diseases The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before The study includes non-randomized purposive sampling and the sample size will be determined by drawing on previous studies
Every patient will receive a thorough clinical assessment that includes a history physical examination electrocardiogram and biochemical testing The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography
The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations
Detailed Description:
In recent years drug-coated balloon DCB therapy has been rapidly accepted in clinical practice especially for the treatment of in-stent restenosis More recently the use of DCB is spreading to de novo CAD The DCB has beneficial features such as allowing local drug delivery without the need to implant any metal Subsequently the duration of dual antiplatelet therapy DAPT is shortened Importantly the DCB is just a delivery vehicle and does not assist in dilating narrowed coronary vessels Thus lesion preparation with standard balloon angioplasty is the key to successful DCB treatment and is essential before the use of a DCB The aim of effective lesion preparation is to gain sufficient luminal enlargement while minimizing coronary dissection As DCBs are fulfilling the concept of leaving nothing behind and guidelines are also recommended as class I indication the use of DCBs have become an alternative therapeutic option for the treatment of ISR small de novo vessel Till to date no such type of study conducted in Bangladesh Thats why the investigators designed this study with the aim to observe clinical and angiographic outcomes of drug-coated balloon angioplasty after successful revascularization of native coronary lesions among Bangladeshi population which is very essential and relevant in the context of Bangladesh
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NICVD Ethical 2023 32 | OTHER | National Institute of Cardiovascular DiseasesNICVD | None |