Condition category
Circulatory System
Date applied
01/07/2020
Date assigned
01/07/2020
Last edited
01/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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™ Cruz 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™ Cruz 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™ Cruz Stent implanted as part of their clinical care.

What does the study involve?
Participants who are having a Supraflex™ Cruz 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 around 30 other hospitals in the UK

When is the study starting and how long is it expected to run for?
April 2018 to June 2022

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

Who is the main contact?
Mr Cheran Uthirapathi, cheran@smt.in

Trial website

Contact information

Type

Public

Primary contact

Mr Cheran Uthirapathi

ORCID ID

Contact details

Ground Floor
Block 5
Galway Technology Park
Parkmore
Galway
H91 R9YR
Ireland
+353 91397472
cheran@smt.in

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 246372

Study information

Scientific title

Prospective evaluation of thin-strut biodegradable polymer-coated Supraflex sirolimus-eluting stents in an all-comers patient population (S-FLEX UK-II)

Acronym

S-FLEX UK-II

Study hypothesis

To evaluate the clinical safety and performance of thin-strut biodegradable polymer-coated Supraflex Cruz sirolimus-eluting stents in an all-comers patient population requiring stent implantation.

Ethics approval

Approved 22/08/2019, South West - Cornwall & Plymouth REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8214; cornwallandplymouth.rec@hra.nhs.uk), ref: 18/SW/0130

Study design

Multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The safety and efficacy of the Supraflex Cruz stent measured through patient interviews and the review of medical notes at the 12 month follow up

Secondary outcome measures

Measured using a review of patient records:
1. Procedural endpoints [at the end of the index procedure (12 months)]
1.1. Device success, lesion success, procedural success
2. Safety and efficacy endpoints [30 days and 12 months]
2.1. Overall stent thrombosis
2.2. All deaths (cardiac, vascular and non-cardiovascular)
2.3. Any myocardial infarction (Q wave and non-Q wave MI)
2.4. Any repeat revascularization (target lesion and target vessel revascularization)
2.5. Target Lesion Failure (TLF)
2.6. Target Vessel Failure (TVF): a composite endpoint of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization

Overall trial start date

09/04/2018

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Symptomatic coronary disease
3. Clinical indication for PCI and stenting of at least one coronary lesion visually confirmed on coronary angiography
4. Only Supraflex Cruz stent(s) is/are to be implanted into the coronary vasculature during the index procedure
5. Give informed consent to participate in this registry and sign the informed consent form approved by the institutional review board of each registry site before the index PCI
6. Agree to undergo all clinical follow-up procedures specified in the study protocol (S-FLEX UK-II) for this registry

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3,000

Participant exclusion criteria

1. Cardiogenic shock.
2. Pregnant or possibly pregnant
3. Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
4. Scheduled to undergo elective surgery within 12 months post-index PCI
5. Currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry
6. Mental incapacity, unwillingness or language barrier precluding understanding of the registry procedure or cooperation with registry site personnel

Recruitment start date

10/03/2020

Recruitment end date

30/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

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

Trial participating centre

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

Bedford Hostpital
King’s Place Britannia Road
Bedford
MK42 9DJ
United Kingdom

Trial participating centre

Wigan Hospital
Brick Kiln Lane
Wigan
WN1 1XX
United Kingdom

Sponsor information

Organisation

Sahajanand Medical Technologies Pvt. Ltd (SMT)

Sponsor details

Sahajanand Estate
Wakhariawadi-Near Dabholi Char Rasta Ved Road
Surat
395004
India
+353 91397472
cheran@smt.in

Sponsor type

Industry

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.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

30/09/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/07/2020: Trial’s existence confirmed by South West - Cornwall & Plymouth REC.