Collection of information on the long-term results of treatment with the Supraflex™ drug eluting stent (the S-FLEX UK Registry)
| ISRCTN | ISRCTN44076071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44076071 |
| EudraCT/CTIS number | 2015-004513-24 |
| Secondary identifying numbers | 19301 |
- Submission date
- 21/10/2015
- Registration date
- 24/11/2015
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Sahajanand Medical Technologies Pvt. Ltd (SMT)
Sahajanand Estate
Wakhariawadi-Near Dabholi Char Rasta Ved Road
Surat
395004
India
Study information
| Study design | Multi-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prospective evaluation of the Supraflex™ sirolimus-eluting coronary stent system in a 'real-world' patient population: the S-FLEX UK Registry |
| Study objectives | 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(s) | Wales - Regional Ethics Committee 7, 21/05/2015, ref: 15/WA/0121 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/07/2015 |
| Completion date | 31/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/07/2015 |
| Date of final enrolment | 31/01/2016 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Newcastle upon Tyne
NE7 7DN
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Scunthorpe
DN15 7BH
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Exeter
EX2 5DW
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
Hospital/treatment centre
Sahajanand Medical Technologies Pvt. Ltd (SMT)
Sahajanand Estate
Wakhariawadi-Near Dabholi Char Rasta Ved Road
Surat
395004
India
| Website | www.SMTPL.com |
|---|---|
"ROR" |
https://ror.org/01vm4bk04 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication of results through peer reviewed scientific journals, conference presentations and publications on the SMT website. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/01/2019: The intention to publish date has been changed from 29/02/2016 to 30/06/2019
19/02/2018: No publications found, verifying study status with principal investigator.
