Drug-coated Balloon Treatment in Coronary Lesions

Sohag University

Status: Not yet enrolling

Conditions: Drug-coated Balloon

Treatments: Device: Angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06265324

Soh-Med-23-12-04MD

Details and patient eligibility

About

This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions

Full 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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Control

Experimental group

Treatment:

Device: Angioplasty