A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

Boston Scientific

Status: Active, not recruiting

Conditions: Cardiovascular Diseases

Treatments: Device: SYNERGYTM Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT03736226

S2424

Details and patient eligibility

About

A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

Full description

This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Subject must be at least 18 years of age

  • Subject understands and provides written informed consent
  • Subject who is clinically indicated and will have an attempt of at least one SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent
  • Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion criteria

• Exclusion criteria are not required in this study which is an "all comers" study.