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1. What is the goal of the SIZING Registry for STENTYS?
 
a. Collect data on “real-life” use of our stents
 
b. Provide guiding for future indications
 
c. Generate Publications
 
d. Technology adoption in study centers
 
e. All of the above
 
 
 
2. What are the potential benefits for the site to participate in the SIZING Registry?
 
a. Possible involvement for data analysis and publications
 
b. Participate in the largest self-expandable coronary stent registry available to date
 
c. Help guide STENTYS for the development of future studies (scientific)
 
d. All of the above
 
 
 
3. What is NOT a condition for a patient to be included in the SIZING Registry?
 
a. Patients which are scheduled to receive a STENTYS stent (DES or BMS) according to the physicians decision
 
b. Patient who is over legal age, and who is willing to sign an authorization form for collection, transfer and processing of personal data before participation
 
c. Patients needs to be implanted for an on-label indication
 
 
 
4. What is needed prior to allowing a center to start enrolling patients in the SIZING Registry?
 
a. EC approval (if applicable)
 
b. Patient Informed Consent in local language
 
c. Signed agreements
 
d. Training of the site
 
e. DB access
 
f. All of the above
 
 
 
5. What is(are) the endpoint(s) of the SIZING Registry?
 
a. MACEs at procedure and 12 months follow-up
 
b. Device success, Procedure success & Clinical success
 
c. TIMI flow (Reperfusion) at the end of the procedure
 
d. All of the above
 
 
 
6. Is there a mandatory follow-up with QCA or OCT at 6 months?
 
a. Yes
 
b. No
 
c. Only for the patients who are implanted with a BMS
 
 
 
7. Can a patient who will receive a STENTYS stent in an SVG be included in the European SIZING registry?
 
a. Yes
 
b. No
 
c. Yes, but only if it is an ADEPT study site as well
 
 
 
8. If a site has been authorized (= EC approval received, Agreements signed, DB access received) to enrol in SIZING, can any STENTYS patient be enrolled? Choose all that apply:
 
a. Yes, if the patient has signed the approved consent form
 
b. Yes, but only if the patient has been implanted with a 3rd generation device
 
c. Yes, but only if the center is already participating to another clinical study (Apposition IV, Open II or ADEPT)
 
d. Yes, but only if the device is provided free of charge
 
e. Yes, but only if the indication is on-label in the IFU
 
f. Yes, but only if the indication for implant is Bifurcation or ACS.
 
 
 
9. True or false: The SCA, DILEMME and German SIZING Registry are NOT part of the overall European SIZING Registry? (The patients will NOT be analysed together)
 
a. True
 
b. False
 
 
 
10. How many patients are planned to be enrolled in the overall European SIZING Registry?
 
a. Approximately 5000 patients in the whole of Europe
 
b. Approximately 3000 patients in around 100 centers
 
c. Maximum 1500 patients in the whole of Europe
 
d. Minimum 5000 patients worldwide
 
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