Drug-coated Balloon Treatment in Coronary Lesions

Drug-coated Balloon Clinical Trial

Official title:

Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265324
• Other study ID #: Soh-Med-23-12-04MD
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: February 10, 2025

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: Imran Saber
• Phone: 01013818656
• Email: Imransaber2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 10, 2025
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug-coated Balloon

Intervention

Device:
• Angioplasty
Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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.; Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.	6 months