Drug-coated Balloon Treatment in Coronary Lesions

Not Applicable

Not yet recruiting

• Conditions: Drug-coated Balloon
• Interventions: Device: Angioplasty

• Registration Number: NCT06265324
• Lead Sponsor: Sohag University

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

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-04
• Study Start: 2024-02-10
• Study First Submitted QC: 2024-02-10
• Last Update Submitted: 2024-02-10
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-06-10
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Angioplasty	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sohag faculty of medicine; 🇪🇬 Sohag, Egypt