|- candidate number||1176|
|- NTR Number||NTR111|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||4-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||STRESSED study.|
|- Scientific Title||Direct Stenting To reduce Restenosis in Stent Era with Drug elution.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Myocardial infarction, Angina Pectoris|
|- 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;
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.
|- 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 > 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).
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-jan-2010|
|- Target number of participants||600|
Randomisation to Drug Eluted Stenting (DES) without (group Direct), with (group Conventional ) balloon predilatation or provisional stenting (group Provisional).
|- Primary outcome||The primary end point is the mean minimal lumen diameter at follow-up angiography. |
|- Secondary outcome||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.
|- Trial web site||http://www.diagram-zwolle.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J. Klijn|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. A.W.J. Hof, van 't |
|- Sponsor/Initiator ||Isala Klinieken, Locatie Weezenlanden, Department of Cardiology|
(Source(s) of Monetary or Material Support)
|- Publications||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.
|- Brief summary||Title:|
direct Stenting To reduce REStenosis in Stent Era with Drug elution.
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).
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.
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.
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).
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.
|- Main changes (audit trail)|
|- RECORD||4-aug-2005 - 13-dec-2006|
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