💬In plain words
What the trial is, and whether it could suit you
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. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.
The treatment being investigated:
In this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effec
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Patients with acute or chronic coronary syndrome
2. Diagnosis of diabetes
3. Patients undergoing PCI for de novo lesions in native coronary arteries
4. Patients able and willing to provide written informed consent
5. Age ≥ 18 years.
6. Patients able and willing to comply with the study procedures and follow-up.
7. All angiographic inclusion criteria fulfilled:
1. the lesion has been deemed treatable
2. the guidewire has crossed the lesion
3. 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 flow-limiting dissection is seen.
Exclusion Criteria:
1. Lesions located at the left main coronary artery.
2. Patient presents with a ST-elevation myocardial infarction (STEMI).
3. Patient with acute cardiac decompensation or acute cardiogenic shock.
4. Patient with impaired renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
5. 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.
6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
8. Patients unable to take dual antiplatelet therapy for 6-12 months
9. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
11. Anticipated difficulties to complete the angiographic surveillance.
12. Patient with a life expectancy of less than 12 months.
13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
14. 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 study will be recruited
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