Protocol
This is used at screening to identify areas of stress-induced myocardial ischemia.
What is the baseline stress imaging (Pet).
This is the minimum ischemic burden that the patient must have to be eligible for the study.
What is at least 10% ischemic area (2 segments) of the left ventricle as confirmed by the core lab.
How many injections will patients randomized to the treatment arm receive?
What are 22 injections of 0.1 mL).
What is source document verification?
The process of comparing data entered into the EDC system against the original source.
Vendor used to upload eligibility packets.
What is JUDI.
Patients are required to complete these three patient facing documents.
What are the SAQ, EQ-5D-5L and the e-diary.
What are two baseline ECG stress tests per protocol.
Classification of IP in EU and US?
What is BSL-2.
What is the Signant SmartSignals Unified Platform?
The integrated EDC/IRT system used for the study.
The length of time needed to ship clinical supplies (IP, device, lab kits, etc.) on site.
What is 7-14 business days depending on country.
This is the primary objective of the study.
What is the total exercise duration (TED) from a graded treadmill test (ETT), number of angina episodes from a diary and the ischemic burden from stress imaging by PET.
XC001 is administered into the ischemic LV myocardial segments by using this. what?using the Extroducer® at a total dose of 4x1011 vp XC001 (twenty-two [22] injections 0.1ml each). T
What isXC001 Extroducer®
The sole roles responsible for performing kit assignment in a clinical trial.
Who are the blinded pharmacist or site user.
Vendor that supplies ancillary pharmacy kits
Who is ThermoFisher.
These are the vendors who conduct the ETT and imaging analysis.
Who are the blinded core labs.
Types of patients that are eligible for EXACT-2.
What are patients with no other treatment options.
What are 4 vials and 1 device.
The expected percentage of e-diary compliance required from study subjects?
What is 80%
This vendor processes SAEs.
Who is Everest PVG.
These are the blinded safety labs that are monitored throughout the study.
What are troponin (cTnI), nAB titers and VEGF serum
What is pregnancy testing for applicable patients.
What manuals should sites reference for the device?
What are the Study Procedure Instruction Manual and the Instructions for Use.
This is the moment both realize DBL is approaching but the query count is still terrifying.
What is delayed DBL (also knows as collective panic).
Manual clinical supply requests are required IP/device and ancillary supplies may be required when this occurs.
What is when two or more patients are treated on the same day or shortly therafter.