Clareo Health | A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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 \< 26 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.
o 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 Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be \>2
If a non-target lesion is treated, it must be treated first and must be deemed a success.
* Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
You may not be if
Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.)
Left ventricular ejection fraction known to be \< 25%.
Subject had PCI or other coronary interventions within the last 30 days.
