Clinical trial NCT03443999: S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
Official title: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Sirolimus-eluting Stent
Biodegradable Polymers
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.

Brief summary: The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

Detailed description: To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.

The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
3. Treating physician has electively implanted at least one Supraflex Family 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-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 12 months
measure: All Deaths
timeFrame: 12 months
measure: Any Myocardial Infarction (MI)
timeFrame: 12 months
measure: Any Repeat Revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
state: Friesland
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: North Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: North Brabant
city: Blaricum
country: Netherlands
facility: Tergooi Ziekenhuis
state: North Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: South Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: South Holland
city: Terneuzen
country: Netherlands
facility: ZorgSaam Hospital
state: Zeeuws- Vlaanderen
Study officials:
affiliation: Amphia Hospital, Breda, The Netherlands
name: Dr. A.J.J. IJsselmuiden, MD.
role: PRINCIPAL_INVESTIGATOR
References: