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Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland Identifier:
First received: July 19, 2010
Last updated: June 4, 2014
Last verified: June 2014


Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.

The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin


Multicenter open-label randomized trial.

Patient inclusion:

Unselected series of patients in need of large (>3mm) stents only in native vessels irrespective of clinical indication.

Patient exclusion:

In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA).


By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.

Condition Intervention Phase
Coronary Artery Disease
Coronary Thrombosis
Device: Everolimus-eluting stent
Device: Bare-metal stent
Device: Biodegradable Polymer-DES
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Late Clinical Events After Drug-eluting Versus Bare-metal Stents in Patients at Risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination Part II (BASKET-PROVE II)

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 2 years ]
  • Myocardial infarction (MI) [ Time Frame: 2 years ]
    • Any MI
    • Non-fatal MI

  • Target vessel revascularization (TVR) [ Time Frame: 2 years ]
    • Any TVR
    • Non-MI related TVR

  • Composite safety endpoint of cardiac death and non-fatal MI [ Time Frame: 2 years ]
  • Stent thrombosis according to ARC definitions [ Time Frame: 2 years ]
    • Definite
    • Definite or probable
    • Definite, probable or possible

  • Major bleeding including fatal bleeding, i.e., BARC >=3 [ Time Frame: 2 years ]
  • All cause death [ Time Frame: 2 years ]
  • Net clinical benefit = Primary endpoint plus major bleeding [ Time Frame: 2 years ]

Enrollment: 2291
Study Start Date: April 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Everolimus-eluting stent
A Xience Prime stent (Everolimus-eluting stent) is implanted in significant coronary lesions.
Device: Everolimus-eluting stent
Everolimus-eluting stent
Other Name: Xience-Prime stent
Active Comparator: Bare-metal stent
Implantation of a bare-metal stent
Device: Bare-metal stent
Bare metal stent
Other Name: ProKinetik
Experimental: Biodegradable Polymer-DES
Implantation of a Biodegradable Polymer-DES
Device: Biodegradable Polymer-DES
drug-eluting stent with bioabsorbable polymer
Other Name: Nobori stent

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • written informed concent
  • need for large (≥3.0 mm stents only) native vessel stenting

Exclusion Criteria:

  • in-Stent Restenosis or in-Stent Thrombosis
  • bypass graft disease to be stented
  • main stem disease to be stented
  • cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
  • planned surgery within the next 12 months
  • oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
  • active bleeding disorders
  • index-PCI = planned PCI of additional lesion
  • no follow-up (FU) expected/possible
  • History of stroke or TIA (contraindication for prasugrel)
  • known severe hypersensitivity reaction to ASS and/or Prasugrel
  • no compliance expected / no informed consent given
  • enrolled in another study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01166685

Innsbruck, Austria, 6020
Gentofte Hospital
Hellerup, Denmark, 2900
Elisabethen Krankenhaus
Essen, NRW, Germany, 45138
Aarau, AG, Switzerland, 5000
University Hospital
Basel, BS, Switzerland, 4055
St. Gallen, SG, Switzerland
Lugano, TI, Switzerland, 6903
Stadtspital Triemli
Zürich, ZH, Switzerland, 8063
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Study Chair: Christoph A Kaiser, Prof. MD University Hospital Basel Cardiology
  More Information

Pfisterer M, Brunner-La Rocca HP, Rickenbacher P, Hunziker P, Mueller C, Nietlispach F, Leibundgut G, Bader F, Kaiser C; BASKET. Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET. Eur Heart J. 2009 Jan;30(1):16-24. Epub 2008 Nov 25. PMID: 19033260 Pfisterer M, Bertel O, Bonetti PO, Brunner-La Rocca HP, Eberli FR, Erne P, Galatius S, Hornig B, Kiowski W, Pachinger O, Pedrazzini G, Rickli H, De Servi S, Kaiser C; BASKET-PROVE Investigators. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: study protocol and design. Am Heart J. 2008 Apr;155(4):609-14. Epub 2008 Feb 21. PMID: 18371466 Brunner-La Rocca HP, Kaiser C, Pfisterer M; BASKET Investigators. Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET). Eur Heart J. 2007 Mar;28(6):719-25. Epub 2007 Feb 13. PMID: 17298975

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01166685     History of Changes
Obsolete Identifiers: NCT01097187
Other Study ID Numbers: BPII
Study First Received: July 19, 2010
Last Updated: June 4, 2014

Keywords provided by University Hospital, Basel, Switzerland:
coronary artery disease
drug-eluting stent
anti-thrombotic therapy
bare-metal stent
long-term outcome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Thrombosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 28, 2017