Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.diagram-zwolle.nl

Contact information

Type

Scientific

Primary contact

Dr J Klijn

ORCID ID

Contact details

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 426 2997
j.klijn@diagram-zwolle.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR111

Study information

Scientific title

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

Acronym

STRESSED

Study hypothesis

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

Ethics approval received from the METC Isala klinieken Zwolle, 28/06/2005, ref: 04.1178p

Study design

Randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2005

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant 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)

Recruitment start date

01/09/2005

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands

Sponsor information

Organisation

Isala Clinics (Isala klinieken) (The Netherlands)

Sponsor details

Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
+31 (0)38 424 2374
hof@diagram-zwolle.nl

Sponsor type

Hospital/treatment centre

Website

http://www.isala.nl/

Funders

Funder type

Industry

Funder name

Diagram B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25060017

Publication citations

Additional files

Editorial Notes