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Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166685
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : June 5, 2014
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:


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 or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Thrombosis Device: Everolimus-eluting stent Device: Bare-metal stent Device: Biodegradable Polymer-DES Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
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

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

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

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166685

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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
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Study Chair: Christoph A Kaiser, Prof. MD University Hospital Basel Cardiology

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):
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01166685    
Obsolete Identifiers: NCT01097187
Other Study ID Numbers: BPII
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 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:
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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