This application was provisionally approved by consensus, subject to the following information being received. Please provide evidence of favourable independent peer review of the study protocol (Ethical Guidelines for Intervention Studies Appendix 1). Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). This following information will be reviewed, and a final decision made on the application, by Dr Nicola Swain and Ms Rochelle Style 5 Ethics ref: 17/NTA/254 Title: EVOLVE 48 Study Principal Investigator: Dr Seif El-Jack Sponsor: Boston Scientific Corporation Clock Start Date: 30 November 2017 Hector Gonzales was present in person for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Safety and efficacy of the SYNERGY Stent System has been demonstrated in the EVOLVE Clinical Program. The SYNERGY has unique characteristics, and is designed to complete resorption of the polymer shortly following the drug elution at 90 days. The EVOLVE 48 is designed to assess the safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and 44 mm in length (by visual estimate) in native coronary arteries mm to ≤ ≥2.5 mm in diameter (by visual estimate). ≤4.0 Sites outside the United States (US) are being included in this protocol to collect additional 48 mm data to support future FDA approval. This is also an opportunity to collect EU safety and performance data for the current CE Marked 48 mm device. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee noted that insurance provided must be available at equivalent levels to ACC, and must be accessible. Please review chapter 8 of the National Ethics Advisory Committee Ethical guidelines for Intervention Studies and respond to the Committee confirming those ethical standards are met. The Committee requested the following changes to the Participant Information Sheet and Consent Form:
This application was provisionally approved by consensus, subject to the following information being received. Please provide evidence of favourable independent peer review of the study protocol (Ethical Guidelines for Intervention Studies Appendix 1). Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). This following information will be reviewed, and a final decision made on the application, by Dr Nicola Swain and Ms Rochelle Style 5 Ethics ref: 17/NTA/254 Title: EVOLVE 48 Study Principal Investigator: Dr Seif El-Jack Sponsor: Boston Scientific Corporation Clock Start Date: 30 November 2017 Hector Gonzales was present in person for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Safety and efficacy of the SYNERGY Stent System has been demonstrated in the EVOLVE Clinical Program. The SYNERGY has unique characteristics, and is designed to complete resorption of the polymer shortly following the drug elution at 90 days. The EVOLVE 48 is designed to assess the safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate). Sites outside the United States (US) are being included in this protocol to collect additional 48 mm data to support future FDA approval. This is also an opportunity to collect EU safety and performance data for the current CE Marked 48 mm device. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee noted that insurance provided must be available at equivalent levels to ACC, and must be accessible. Please review chapter 8 of the National Ethics Advisory Committee Ethical guidelines for Intervention Studies and respond to the Committee confirming those ethical standards are met. The Committee requested the following changes to the Participant Information Sheet and Consent Form:
nta-12-december-2017-meeting-minutes.docx