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

Prospective evaluation of the Supraflex™ sirolimus-eluting coronary stent system in a 'real-world' patient population: the S-FLEX UK Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN44076071

Enrollment

500

Registered

2015-11-24

Start date

2015-07-10

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

Once a patient has been identified as potentially meeting the inclusion and exclusion criteria written informed consent is obtained prior to the patient’s enrollment. Potential participants will have

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026