STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution

ISRCTN	ISRCTN41213536
DOI	https://doi.org/10.1186/ISRCTN41213536
Secondary identifying numbers	NTR111

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 27/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr J Klijn
Scientific

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands

Phone	+31 (0)38 426 2997
Email	j.klijn@diagram-zwolle.nl

Study information

Study design	Randomised active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution
Study acronym	STRESSED
Study objectives	To investigate whether a strategy of direct stenting without pre-dilatation is associated with a reduced incidence of restenosis at nine month follow-up angiography, compared to conventional stenting with pre-dilatation or compared to a strategy of provisional stenting. Please note that as of 24/06/2008 more details on the sources of funding have been added to this record (i.e., funding now confirmed). This can be seen below in the sources of funding section.
Ethics approval(s)	Ethics approval received from the METC Isala klinieken Zwolle, 28/06/2005, ref: 04.1178p
Health condition(s) or problem(s) studied	Angina pectoris, myocardial infarction
Intervention	Pecutaneous coronary intervention: Randomisation to drug eluted stenting (DES) without (group Direct), with (group Conventional) balloon predilatation or provisional stenting (group Provisional). 600 patients with stable or unstable angina, who are candidate for a percutaneous transluminal coronary angioplasty (PTCA), will be randomised to direct stenting, provisional stenting or pre-delatation. After nine months a follow up angiogram will be made. After 24 month a follow-up will be done.
Intervention type	Procedure/Surgery
Primary outcome measure	Mean minimal lumen diameter at follow-up angiography.
Secondary outcome measures	1. Clinical procedural success defined as angiographic success without major adverse cardiac events (MACE): death, myocardial infarction, or myocardial revascularisation by repeat angioplasty or coronary bypass surgery 2. Rate of major adverse clinical events during the nine and 24-month follow-up period
Overall study start date	01/09/2005
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
Key inclusion criteria	1. Men and women less than 85 years of age 2. Stable or unstable angina pectoris or a recent (less than 30 days) myocardial infarction with objective evidence of myocardial ischaemia 3. Lesion with more than 50% and less than 100% diameter stenosis according to the estimate of the investigator 4. Single American College of Cardiology/American Heart Association (ACC/AHA) task force classification type A, B1 or B2 non-calcified target lesion 5. No contraindication to inhibition of platelet function with aspirin and ticlopidine or clopidogrel
Key exclusion criteria	1. Acute ST elevation myocardial infarction 2. Unstable angina pectoris, classified as Braunwald category IIIB or C 3. Bifurcation lesions situated with a side branch more than 20 mm in diameter 4. Left main coronary artery lesions 5. Ostial lesions 6. Left ventricular ejection fraction of less than 30% 7. Contraindication for follow-up angiography (severe peripheral vessel disease, creatine-clearance less than 30 ml/min)
Date of first enrolment	01/09/2005
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Diagram B.V. Zwolle

Zwolle
8011 NB
Netherlands

Sponsor information

Isala Clinics (Isala klinieken) (The Netherlands)
Hospital/treatment centre

Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands

Phone	+31 (0)38 424 2374
Email	hof@diagram-zwolle.nl
Website	http://www.isala.nl/
"ROR"	https://ror.org/046a2wj10

Funders

Funder type

Industry

Diagram B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No