A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of… (NCT06492174) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
United States20 participantsStarted 2024-10-07
Plain-language summary
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinical Inclusion Criteria:
* Subject must be at least 18 years of age
* Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
* Subject is eligible for percutaneous coronary intervention (PCI)
* Subject is willing to comply with all protocol-required follow-up evaluation
* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure
Angiographic Inclusion Criteria (visual estimate)
* In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) \> 2.0 mm and ≤ 4.0 mm.
* Target lesion length must be ≤ 36 mm (by visual estimate) and must be covered by only one balloon.
* Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic patients (\>70% and \<100% in asymptomatic patients) prior to lesion pre-dilation.
* Target lesion must be successfully pre-dilated.
Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Inst…