PAclitaxel-eluting Balloon in Primary PCI in Amsterdam; Pilot Study

NCT01274728 | Unknown DMC

• 1 other identifier: wo 09.070
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical evaluation will study the feasibility and safety of a CE-marked paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons provide the potential advantage of delivering a anti-proliferative drug, without the disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction; Primary percutaneous coronary intervention; Drug-eluting balloon; Bivalirudin

Outcome Measures

Primary Outcomes (1)

• Major acute coronary event

  Defined as 1. any death in which cardiac cause can not be excluded (death due to proximate cardiac cause, unwitnessed death, death of unknown cause, all procedure-related deaths) 2. recurrent MI in the target vessel area (if no infarct localization is identified it is regarded target vessel related) 3. target lesion revascularization (PCI within 5mm of the balloon(stent) area borders or CABG of the target vessel)

  1 month

Secondary Outcomes (10)

• Cross-over to bail-out stenting

  1, 6 and 12 months

• Death from any cause

  1, 6 and 12 months

• Major acute coronary event

  6 and 12 months

• In-hospital major acute coronary event

  index hospitalisation

• Recurrent MI non-target vessel related

  1, 6 and 12 months

Study Arms (1)

ST-elevated myocardial infarction

Those with a condition of chestpain (or equal complains) and ECG changes confirming STEMI.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention with at least use of drug-eluting balloon and if necessary cross-over to bail-out stenting with BMS.

ST-elevated myocardial infarction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are presented at the emergency room or in ambulance with STEMI

You may qualify if:

• Acute myocardial infarction eligible for primary PCI:
• min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction
• reperfusion is expected to be feasible within 12 hours after onset of complaints
• Infarct related artery eligible for PPCI including stent implantation. Diameter of IRA ≥ 2.5 mm, ≤ 4 mm.
• Infarction is caused by a de novo lesion in a native coronary artery

You may not qualify if:

• Age \< 18
• Reperfusion not feasible within 12 hours after onset of complaints
• Failed thrombolysis
• Infarct related artery unsuitable for PCI
• Sub-acute stent thrombosis
• STEMI caused by in-stent re-stenosis
• Infarct related vessel / target vessel SVG or LIMA
• Contraindication or resistance for bivalirudin, fondaparinux ,aspirin, clopidogrel and/or prasugrel.
• Participation in another clinical study, interfering with this protocol
• Uncertain neurological outcome e.g. resuscitation
• Intubation/ventilation
• Refusal to receive blood transfusion
• Platelet number \< 100.000 x 10\^9/L
• Planned major surgery within 6 weeks
• Expected mortality from any cause within the next 12 months

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

RECRUITING

Related Publications (16)

• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

  PMID: 12517460 BACKGROUND

• Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.

  PMID: 10547403 BACKGROUND

• De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008 May 7;126(1):37-44. doi: 10.1016/j.ijcard.2007.03.112. Epub 2007 Jun 4.

  PMID: 17544528 BACKGROUND

• Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.

  PMID: 16971717 BACKGROUND

• Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104. doi: 10.1056/NEJMoa062006.

  PMID: 16971716 BACKGROUND

• De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.

  PMID: 18394731 BACKGROUND

• Brar SS, Leon MB, Stone GW, Mehran R, Moses JW, Brar SK, Dangas G. Use of drug-eluting stents in acute myocardial infarction: a systematic review and meta-analysis. J Am Coll Cardiol. 2009 May 5;53(18):1677-89. doi: 10.1016/j.jacc.2009.03.013.

  PMID: 19406344 BACKGROUND

• Degertekin M, Serruys PW, Tanabe K, Lee CH, Sousa JE, Colombo A, Morice MC, Ligthart JM, de Feyter PJ. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003 Dec 2;108(22):2747-50. doi: 10.1161/01.CIR.0000103666.25660.77. Epub 2003 Nov 24.

  PMID: 14638542 BACKGROUND

• 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 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.

  PMID: 15500897 BACKGROUND

• Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

  PMID: 17101615 BACKGROUND

• Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.

  PMID: 18536865 BACKGROUND

• Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

  PMID: 19487593 BACKGROUND

• Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.

  PMID: 20052480 BACKGROUND

• Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008 May 22;358(21):2218-30. doi: 10.1056/NEJMoa0708191.

  PMID: 18499566 BACKGROUND

• Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• Vranckx P, Kint PP, Morel MA, Van Es GA, Serruys PW, Cutlip DE. Identifying stent thrombosis, a critical appraisal of the academic research consortium (ARC) consensus definitions: a lighthouse and as a toe in the water. EuroIntervention. 2008 Aug;4 Suppl C:C39-44. No abstract available.

  PMID: 19202690 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biochemistry, haematology

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• R.J. van der Schaaf, MD, PhD

  Onze Lieve Vrouwe Gasthuis Amsterdam

  PRINCIPAL INVESTIGATOR

• M.T. Dirksen, MD, PhD

  Onze Lieve Vrouwe Gasthuis Amsterdam

  PRINCIPAL INVESTIGATOR

• N.S. Vos, MD

  Onze Lieve Vrouwe Gasthuis Amsterdam

  STUDY CHAIR

• J.P.H. Herrman, MD, PhD

  Onze Lieve Vrouwe Gasthuis

  STUDY DIRECTOR

Central Study Contacts

R.J van der Schaaf, MD, PhD

CONTACT

+31-20-5993440; R.J.vanderSchaaf@olvg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: November 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

NL (1)