NCT03443999

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2018Dec 2027

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

9.3 years

First QC Date

February 16, 2018

Last Update Submit

April 22, 2026

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseSirolimus-eluting StentBiodegradable Polymers

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.

    12 months

Secondary Outcomes (6)

  • Target Vessel Failure (TVF)

    12 months

  • Major Adverse Cardiac Events (MACE)

    12 months

  • Stent Thrombosis

    12 months

  • All Deaths

    12 months

  • Any Myocardial Infarction (MI)

    12 months

  • +1 more secondary outcomes

Interventions

Supraflex Family Sirolimus-eluting Coronary Stent SystemDEVICE

Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 18 years
  • 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
  • Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
  • The patient is willing and able to cooperate with study procedures and required follow up visits

You may not qualify if:

  • Women with known pregnancy or who are lactating
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
  • Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Amphia Ziekenhuis

Breda, North Brabant, 4818 CK Breda, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

Tergooi Ziekenhuis

Blaricum, North Holland, 1261 AN, Netherlands

RECRUITING

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Post bus 444 3300 AK, Netherlands

RECRUITING

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

ZorgSaam Hospital

Terneuzen, Zeeuws- Vlaanderen, 4535 PA, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dr. A.J.J. IJsselmuiden, MD.

    Amphia Hospital, Breda, The Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibhor Bhatia

CONTACT

+919049528863vibhor.bhatia@sahmed.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 23, 2018

Study Start

February 27, 2018

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(7)