Valentines trial

1.0 INCLUSION CRITERIA
Patients, male or female, >18 years of age Patients who present electively with in-stent restenosis of a previously placed stent documented by coronary The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc) The patient is able and wil ing to conform to the requirements of the study and voluntarily signs an Informed Consent.
2.0 EXCLUSION CRITERIA
The patient has had an acute myocardial infarction within the last 48 hours The patient has a co-morbid il ness (i.e. any il ness likely to limit his/her life expectancy to <8 months) Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications) Lesion(s) requiring vascular brachytherapy treatment for in-stent restenosis Lesion(s) located in the left main coronary artery The patient has had previous therapeutic radiation to the target vessel The patient is unable to take antiplatelet therapy for at least 6 months Patients with history of major surgery within the last month 3.0 DEMOGRAPHICS/MEDICAL HISTORY
Left Ventricular Ejection Fraction __________ % 4.0 BASELINE PRESENTATION
 Other, specify: _________________________ 5.0 CARDIAC ENZYMES
6.0 PROCEDURAL MEDICATIONS
6.0 DISCHARGE
Did the patient experience any major adverse events prior to discharge? 6.2.1.1 Days post drug-eluting bal oon treatment 6.2.2.1 Days post drug-eluting bal oon treatment 6.2.2.2 Was there ST elevation on the ECG 6.2.3.1 Days post drug-eluting bal oon treatment 6.2.4.1 Days post drug-eluting bal oon treatment 6.2.5.1 Days post drug-eluting bal oon treatment Routine medications at discharge(check al that apply) 7.0 PROCEDURE
1 = Proximal, 2=Mid, 3=Distal, 4=Ostial, 5 = Anast., 6=Bifurcation, 99=Unknown 0=No, 1=Yes0=No, 1=BMS, specify: ________________________, 2=Taxus, 3=Cypher, 4= Endeavor, 5= Xience V, 6=Promus, 7=Covered Stent, 99=Unknown stent type, 88=Other DES, specify: _______________________ 1=<2 months, 2=≥2months, <6 months, 3=≥6 months, <1 year, 4=≥1 year 1=De Novo, 2=VBT Failure, 3= ISR of BMS, 4=ISR of DES, 5=Restenotic (no stent), 1=Focal, 2=10-20mm, 3=Diffuse, 4=Proliferative, 5=Multi-focal, 6= Occlusive 0=No, 1=Yes  if “Yes”, please complete a Narrative form 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB (mandatory), 2=Post DEB, 3=Both Pre and Post DEB
0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Filter device, 2=Occlusive device 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 0=No, 1=Pre DEB, 2=Post DEB, 3=Both Pre and Post DEB 8.0 Follow Up
Days since drug-eluting bal oon treatment Did the patient experience any major adverse events since the date of last contact? 8.2.1.1 Days post drug-eluting bal oon treatment 8.2.2.1 Days post drug-eluting bal oon treatment 8.2.2.2 Was there ST elevation on the ECG 8.2.3.1 Days post drug-eluting bal oon treatment  Other, specify: _________________________ 8.2.1.1 Days post drug-eluting bal oon treatment  Other, specify: _________________________ 8.2.5.1 Days post drug-eluting bal oon treatment Did the patient have a cardiac catherization since last contact? 8.3.1 Was the film submit ed to the Angiographic Core Laboratory? Routine medications at time of fol ow up(check al that apply) 8.5.1 If discontinued, days post PCI thienopyridine was stopped 9.0 NARRATIVE FORM
Days since drug-eluting bal oon treatment of occurance described below

Source: http://www.valentines-trial.com/kunden/valentinestrial/content/e9635/e7892/e8048/e9454/e9455/ValentinesTrial_CRF_Source_Worksheet.pdf