Collection of information on the long-term results of treatment with the Supraflex™ drug eluting stent (the S-FLEX UK Registry)

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis; Circulatory System; Atherothrombosis

• Registration Number: ISRCTN44076071
• Lead Sponsor: Sahajanand Medical Technologies Pvt. Ltd (SMT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-24
• Study Completion: 2016-01-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Aged 18 years or over
2. The patient, or legal representative, consents to participate and has authorised the collection and release of his/her medical information
3. Treating physician has electively implanted at least one Supraflex™ Stent as part of the patient’s planned
clinical care
4. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria

1. Women with known pregnancy or who are lactating
2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical
reasons)
3. Currently participating in another study that has not completed the primary endpoint or that clinically
interferes with the current registry requirements
4. Planned surgery within 6-months of PCI unless dual anti-platelet therapy is maintained throughout the perioperative period

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and efficacy of the Supraflex stent is measured through patient interviews and the review of medical notes at the 12 month follow up.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall stent thrombosis measured using an angiogram at 12 months<br> 2. Overall mortality rate is determined by contacting the patients' GP at 12 months<br> 3. Myocardial infarction rate is measured using a 12-lead ECG at 12 months<br> 4. Target vessel failure measured using an angiogram at 12 months<br> 5. Rate of major adverse cardiac events measured through patient interviews and review of medical notes at 12 months<br>