StudyFinder
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
Status: Recruiting
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.
Sex: Male or Female
Age: 18 years and over
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)
Contact(s): Melanee Schimmel, BSN, RN - mschimm2@hfhs.org
Principal Investigator: Asaad Nakhle
Principal Investigator ID: anakhle2@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov