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AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
The AGENT DCB STANCE study will compare the AGENT Paclitaxel Coated Balloon Catheter to standard of care treatment with drug-eluting stents and/or balloon medical procedure to open blocked or narrowed blood vessels.
Contact(s):
Melanee Schimmel, BSN, RN - mschimm2@hfhs.org
Principal Investigator: Asaad Nakhle
Principal Investigator ID: anakhle2@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
Healthy Volunteers:
Inclusion Criteria:
• Must be at least 18 yrs of age
• Understands and the willingness to comply with all study required follow-up evaluation
• Women of child-bearing potential must agree to use a reliable method of contraception for 1 year.
Exclusion Criteria:
• Other serious medical illness that may reduce life expectancy to less than 1 year.
• Serious problem with substances (alcohol, cocaine, heroin, etc.)
• Currently participating in another experimental drug/device study that has not met the outcome the study is measuring
• Is pregnant and nursing
• Has had a non-surgical procedure used to open narrowed or blocked coronary arteries with a balloon or stent
• Been diagnosed with severe heart failure within the past 6 months
• Known allergy to paclitaxel or other parts of the medical devices that are used.
• Severe renal failure
Interventions: Drug/Device: AGENT Drug-Coated Balloon
Conditions: Coronary Artery Disease
Keywords: , coronary artery disease (CAD), de novo lesions in native Coronary arteries, drug coated balloon, percutaneous coronary intervention (PCI)