Condition category
Circulatory System
Date applied
21/10/2015
Date assigned
24/11/2015
Last edited
24/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Coronary heart disease (CHD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CHD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). When arteries are blocked or narrowed, the heart does not receive enough blood to function properly, which can cause pain and tightness in the chest (angina), or a heart attack. An angioplasty is a common procedure where a thin tube (catheter) is placed inside the narrowed blood vessel. A small balloon on the tip of the catheter is gradually inflated to reopen the artery and flatten the blockage against the artery wall. In some cases, the surgeon also places a mesh-like tube (stent) into the artery to keep it open. One of the main problems following this type of surgery is that the artery may re-narrow and become blocked again (restenosis), as the cells which make up the obstruction multiply (proliferate). New techniques have been developed where the stent placed in the artery is coated in a drug which prevents cell proliferation (drug-eluting stent). The Supraflex™ Stent is a type of drug-eluting stent which uses the drug sirolimus to prevent restenosis. The aim of this study is to look at patients who have had a Supraflex™ Stent to find out if it is a safe and efficient way of preventing restenosis and future heart problems.

Who can participate?
Adults who have had a Supraflex™ Stent implanted as part of their clinical care.

What does the study involve?
Participants who are having a Supraflex™ Stent implanted are asked for their consent to take part in the study. The patients are asked to attend a follow-up appointment 12 months after their operation so that any blockages in their stent (stent thrombosis) can be measured, using an angiogram (a scan of the coronary arteries). The patients are also interviewed in order to find out whether there have been any problems since their operation.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to patients taking part in this study.

Where is the study run from?
Freeman Hospital (lead centre) and 10 other hospitals in the UK.

When is the study starting and how long is it expected to run for?
July 2015 to January 2016

Who is funding the study?
Sahajanand Medical Technologies Pvt. Ltd (India)

Who is the main contact?
Mr Cheran Uthirapathi

Trial website

Contact information

Type

Scientific

Primary contact

Mr Cheran Uthirapathi

ORCID ID

Contact details

Sahajanand Medical Technologies Pvt. Ltd (SMT)
Sahajanand Estate
Wakhariawadi-Near Dabholi Char Rasta Ved Road
Surat
395004
India

Additional identifiers

EudraCT number

2015-004513-24

ClinicalTrials.gov number

Protocol/serial number

19301

Study information

Scientific title

Prospective Evaluation of the Supraflex™ Sirolimus-Eluting Coronary Stent System in a 'Real-World' Patient Population: S-FLEX UK Registry

Acronym

Study hypothesis

The aim of this study is to evaluate the safety and efficacy of the Supraflex™ sirolimus-eluting coronary stent system in a 'real world' patient population requiring stent implantation.

Ethics approval

Wales - Regional Ethics Committee 7, 21/05/2015, ref: 15/WA/0121

Study design

Multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis

Intervention

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 up to 24 hours to consider the information presented to them, after which signed consent will be sought. It should be noted that the patient would have already provided consent for the DES implantation procedure as per normal standard of care at the investigational site.

The total duration of observation is 12 months with a follow up at 12 months.
The total duration of the follow-up at 12 months is no longer than 1 hour.

We will simply identify those who have had the Supraflex stent, so they can be followed up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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

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

Overall trial start date

10/07/2015

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

Participant 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

Recruitment start date

10/07/2015

Recruitment end date

31/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Blackpool Teaching Hospital
38 Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Trial participating centre

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Eastbourne District General Hospital
King's Drive
Eastbourne,
BN21 2UD
United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Milton Keynes University Hospital
H8 Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Sahajanand Medical Technologies Pvt. Ltd (SMT)

Sponsor details

Sahajanand Medical Technologies Pvt. Ltd (SMT)
Sahajanand Estate
Wakhariawadi-Near Dabholi Char Rasta Ved Road
Surat
395004
India

Sponsor type

Hospital/treatment centre

Website

www.SMTPL.com

Funders

Funder type

Industry

Funder name

Sahajanand Medical Technologies Pvt. Ltd (SMT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results through peer reviewed scientific journals, conference presentations and publications on the SMT website.

Intention to publish date

29/02/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes