STRESSED study.

Recruiting

Conditions: Stable or unstable angina pectoris or a recent (<30 days) myocardial infarction with objective evidence of myocardial ischemia.

Registration Number: NL-OMON25680

Lead Sponsor: Dr AWJ van ¡¦t HofIsala Klinieken, locatie WeezenlandenDepartment of CardiologyGroot Wezenland 208011 JW Zwolle

Brief Summary: 1. Laarman G, Muthusamy TS, Swart H, Westendorp I, Kiemeneij F, Slagboom T, van der Wieken R. Direct coronary stent implantation: safety, feasibility, and predictors of success of the strategy of direct coronary stent implantation. Catheter Cardiovasc Interv 2001 Apr;52(4):443-448 2. Le Breton H, Boschat J, Commeau P, Brunel P, Gilard M, Breut C, Bar O, Geslin P, Tirouvanziam A, Maillard L, Moquet B, Barragan P, Dupouy P, Grollier G, Berland J, Druelles P, Rihani R, Huret B, Leclercq C, Bedossa M. Randomised comparison of coronary stenting with and without balloon predilatation in selected patients. Heart 2001 Sep;86(3):302-308. 3. Carrie D, Khalife K, Citron B, Izaaz K, Hamon M, Juiliard JM, Leclercq F, Fourcade J, Lipiecki J, Sabatier R, Boulet V, Rinaldi JP, Mourali S, Fatouch M, El Mokhtar E, Aboujaoude G, Elbaz M, Grolleau R, Steg PG, Puel J; Benefit Evaluation of Direct Coronary Stenting Study Group. Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. BET (Benefit Evaluation of Direct Coronary Stenting) Study Group. Am J Cardiol 2001 Mar 15;87(6):693-698 4. Taylor AJ, Broughton A, Federman J, Walton A, Keighley C, Haikerwal D, Krawczyszyn M, Shaw J, Goods C. Efficacy and safety of direct stenting in coronary angioplasty. J Invasive Cardiol 2000 Nov;12(11):560-565. 5. Veselka J, Mates M, Tesar DB, Aschermann M, Urbanova T, Honek. Direct stenting without predilatation: a new approach to coronary intervention. Coron Artery Dis 2000 Sep;11(6):503-507. 6. Ormiston JA, Webster MW, Ruygrok PN, Elliott JM, Simmonds MB, Meredith IT, Devlin GP, Stewart JT, Dixon SR, Price S, Ellis CJ, West TM. A randomized study of direct coronary stent delivery compared with stenting after predilatation: the NIR future trial. On behalf of the NIR Future Trial Investigators. Catheter Cardiovasc Interv 2000 Aug;50(4):377-381. 7. de la Torre Hernandez JM, Gomez I, Rodriguez-Entem F, Zueco J, Figueroa A, Colman T. Evaluation of direct stent implantation without predilatation by intravascular ultrasound. Am J Cardiol 2000 Apr 15;85(8):1028-1030. 8. Wilson SH, Berger PB, Mathew V, Bell MR, Garratt KN, Rihal CS, Bresnahan JF, Grill DE, Melby S, Holmes DR Jr. Immediate and late outcomes after direct stent implantation without balloon predilation.. J Am Coll Cardiol 2000 Mar 15;35(4):937-943. 9. PREDICT, Pre-dilatation vs. Direct stenting In Coronary Treatment, unpublished data. 10. Sick PB, Woinke M, Lauer B, Gelbrich G, Schuler G. Angiographic long term results in coronary lesions after primary stenting in comparison with balloon dilatation followed by stent implantation: a multifactorial ANOVA and regression analysis. Circulation 2001;1894(abstract). 11. Foley DP, Pieper M, Wijns W, Suryapranata H, Grollier G, Legrand V, de Scheerder I, Hanet C, Puel J, Mudra H, Bonnier HJ, Colombo A, Thomas M, Probst P, Morice M, Kleijne J, Serruys PW; MAGIC 5L investigators. The influence of stent length on clinical and angiographic outcome in patients undergoing elective stenting for native coronary artery lesions; final results of the Magic 5L Study. Eur Heart J 2001;22:1585-93. 12. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary Revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-8. 13. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42. 14. McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23;364(9444):1519-21 15. Niroomand F, Hauer O, Tiefenbacher CP, Katus HA, Kuebler W. Influence of alcohol consumption on restenosis rate after percutaneous transluminal coronary angioplasty and stent implantation. Heart. 2004 Oct;90(10):1189-93.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

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;

Exclusion Criteria

1. Acute ST elevation myocardial infarction;

2. Unstable angina pectoris, classified as Braunwald category IIIB or C;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point is the mean minimal lumen diameter at follow-up angiography.

Secondary Outcome Measures

Name	Time	Method
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;<br /><br>2. Rate of major adverse clinical events during the 9 and 24-month follow-up period.