Drug-coated BalloonNCT06265324
Drug-coated Balloon Treatment in Coronary Lesions
A study testing Angioplasty in people with Drug-coated Balloon, run by Sohag University at 1 site in Egypt.
Trial summary
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-coated Balloon
- What is being tested?
- Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.
Who cannot join
- Severe renal impairment ( Cr.Cl. < 45 ml/min ).
- Sever heart failure or liver cell failure .
- Patients with contraindications to coronary angiography or invasive procedures.
- Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag faculty of medicine
Sohag
Sharaf Eldin Shazly, PHD, 0112 9999792
Imran Saber, MA
About this study
Official title: Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
Read the 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
- Conditions
- Drug-coated Balloon
- Being tested
- Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastyDevice
Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Device: Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-coated BalloonStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imran Saber Mohamed, Sohag University
- Investigators
- Sharaf Eldin Shazly, PHD, Study director, Sohag faculty of medicineMohammed Abdelwahab, PHD, Study chair, Sohag faculty of medicineImran Saber, MA, Principal investigator, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265324
- Sponsor's protocol ID
- Soh-Med-23-12-04MD
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate
- ClinicalTrials.gov ID
- NCT06265324
- Acronym / sponsor ID
- Soh-Med-23-12-04MD
- Conditions
- Drug-coated Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Angioplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.
Key exclusion criteria (6 listed)
- Severe renal impairment ( Cr.Cl. < 45 ml/min ).
- Sever heart failure or liver cell failure .
- Patients with contraindications to coronary angiography or invasive procedures.
- Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioplastyDrug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions | Device | Control |
Primary outcome
Major adverse cardiac events at 6 months
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharaf Eldin Shazly, PHD study director
Sohag faculty of medicine
Mohammed Abdelwahab, PHD study chair
Sohag faculty of medicine
Imran Saber, MA principal investigator
Sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty in people with Drug-coated Balloon, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Saber (01013818656, Imransaber2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.