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This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty | Device | Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events at 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.
| 6 months |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imran Saber | Contact | 01013818656 | Imransaber2014@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sharaf Eldin Shazly, PHD | Sohag faculty of medicine | Study Director |
| Mohammed Abdelwahab, PHD | Sohag faculty of medicine | Study Chair |
| Imran Saber, MA |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag faculty of medicine | Sohag | Egypt |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| Sohag faculty of medicine |
| Principal Investigator |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |