To investigate whether a strategy of direct stenting without pre-dilatation is associated with a reduced incidence of restenosis at 9 month follow-up angiography, compared to conventional stenting with pre-dilatation or compared to a strategy of…
ID
Bron
Verkorte titel
Aandoening
Stable or unstable angina pectoris or a recent (<30 days) myocardial infarction with objective evidence of myocardial ischemia.
Ondersteuning
Isala Klinieken, locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
8011 JW Zwolle
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary end point is the mean minimal lumen diameter at follow-up angiography.
Achtergrond van het onderzoek
Title:
STRESSED study;
direct Stenting To reduce REStenosis in Stent Era with Drug elution.
Background:
Direct stenting (without pre-dilatation) has been shown to be a safe and effective treatment modality in elective patients as well as in patients who undergo angioplasty (PCI) because of unstable angina. Success rates vary from 90-98%. In most studies it has been shown to reduce procedure length, the use of contrast agent and the number of balloons and wires and therefore has been shown to reduce procedure related costs (1-8).
Objective:
To investigate whether a strategy of direct stenting without pre-dilatation is associated with a reduced incidence of restenosis at 9 month follow-up angiography, compared to conventional stenting with pre-dilatation or compared to a strategy of provisional stenting.
Design:
600 patients with stable or unstable angina, who are candidate for a PTCA, will be randomized to direct stenting, provisional stenting or pre delatation.
After 9 month a follow up angiogram will be made. After 24 month a follow-up will be done.
End Points:
Primary
The primary end point, is the so called ¡¥Late Loss¡¦, defined as the difference in minimal lumen diameter between the first and the follow-up angiogram (derived from two orthogonal views (by the quantitative coronary angiography laboratory).
Secondary
1. Clinical procedural success defined as angiographic success without major adverse cardiac events (MACE): death, myocardial infarction, or myocardial revascularization by repeat angioplasty or coronary bypass surgery.
2. Rate of major adverse clinical events during the 9 and 24-month follow-up period.
Doel van het onderzoek
To investigate whether a strategy of direct stenting without pre-dilatation is associated with a reduced incidence of restenosis at 9 month follow-up angiography, compared to conventional stenting with pre-dilatation or compared to a strategy of provisional stenting.
Onderzoeksproduct en/of interventie
PCI:
Randomisation to Drug Eluted Stenting (DES) without (group Direct), with (group Conventional ) balloon predilatation or provisional stenting (group Provisional).
Publiek
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Wetenschappelijk
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Men and Women less than 85 years of age;
2. Stable or unstable angina pectoris or a recent (<30 days) myocardial infarction with objective evidence of myocardial ischemia;
3. Lesion with > 50% and < 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 > 2.0 mm in diameter;
4. Left main coronary artery lesions;
5. Ostial lesions;
6. Left ventricular ejection fraction of <30%;
7. Contra-indication for follow-up angiography (severe peripheral vessel disease, creatine-clearance < 30 ml/min).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL80 |
| NTR-old | NTR111 |
| Ander register | : N/A |
| ISRCTN | ISRCTN41213536 |
Samenvatting resultaten
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