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Compares treatment options for Diabetes Mellitus
Official title Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus
ClinicalTrials.gov ID: NCT07303439
What this study is testing
- What it's testing
- Purpose of this study: The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with acute or chronic coronary syndrome
- Diagnosis of diabetes
- Patients undergoing PCI for de novo lesions in native coronary arteries
- Patients able and willing to provide written informed consent
- Age ≥ 18 years.
You likely can't join if
- Lesions located at the left main coronary artery.
- Patient presents with a ST-elevation myocardial infarction (STEMI).
- Patient with acute cardiac decompensation or acute cardiogenic shock.
- Patient with impaired renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
- Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure...
- Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
See the full eligibility criteria
- Patients with acute or chronic coronary syndrome
- Diagnosis of diabetes
- Patients undergoing PCI for de novo lesions in native coronary arteries
- Patients able and willing to provide written informed consent
- Age ≥ 18 years.
- Patients able and willing to comply with the study procedures and follow-up.
- All angiographic fulfilled:
- the lesion has been deemed treatable
- the guidewire has crossed the lesion
- the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \>2, and there is no evidence of...
- Lesions located at the left main coronary artery.
- Patient presents with a ST-elevation myocardial infarction (STEMI).
- Patient with acute cardiac decompensation or acute cardiogenic shock.
- Patient with impaired renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
- Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.
- Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
- Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
- Patients unable to take dual antiplatelet therapy for 6-12 months
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
- Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
- Anticipated difficulties to complete the angiographic surveillance.
- Patient with a life expectancy of less than 12 months.
- Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
- The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the...
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, County Dublin, Ireland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, County Dublin, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.