Research with human participants

Overview of medical research in the Netherlands

The STARS-Trial: To Assess Stent Apposition by Optical Coherence Tomography (OCT) of the Svelte Sirolimus-Eluting Coronary Stent Systems (IDS and RX) Compared to the Abbott Vascular Xience Everolimus-Eluting Coronary Stent System for the Treatment of Atherosclerotic Lesions in a Randomized Study

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Last updated:

Superiority of stent apposition as assessed by OCT

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Coronary artery disorders
Study type
Interventional

ID

NL-OMON55040

Source

ToetsingOnline

Brief title

STARS

Condition

  • Coronary artery disorders

Synonym

Coronary artery disease; atherosclerosis

Research involving

Human

Sponsors and support

Primary sponsor :
Amphia Ziekenhuis
Source(s) of monetary or material Support :
De stents die gebruikt gaan worden zijn stents die al dagelijks gebruikt worden.

Intervention

Keyword :
Apposition, OCT, Stent

Outcome measures

Primary outcome

Stent appossition

Secondary outcome

Stent expansion

Edge dissection

Total number of balloons used

Background summary

The Svelte Sirolimus-eluting coronary stent is compared to the Abbott Vascular
Xience Everolimus-eluting stent. It is expected that there will be superiority
in stent appossion due to the fact that the balloon system of the Svelte
utilizes a non-compliant balloon, which makes is possible to deploy using
higher pressures than conventional stent delivery balloons.

Study objective

Superiority of stent apposition as assessed by OCT

Study design

Prospective, single-blind, single-center randomized study

Intervention

Svelte Sirolimus-eluting stents vs. Abbott Vascular Xience Everolimus-eluting
stent

Study burden and risks

All study stents are CE-marked and used in daily clinical practice. The OCT
imaging will prolong the procedure for an estimated 10 minutes.

Public
Amphia Ziekenhuis

Amphia ziekenhuis 21
Breda 4818CK
NL
Scientific
Amphia Ziekenhuis

Amphia ziekenhuis 21
Breda 4818CK
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- Subject has symptomatic coronary artery disease with objective evidence of
ischemia or silent ischemia

Exclusion criteria

- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmia, or ongoing
intractable angina;

Design

Study phase :
4
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
250
Type :
Actual

Medical products/devices used

Generic name :
Drug-eluting stents
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL73037.100.20