PAclitaxel-eluting Balloon in Primary PCI in Amsterdam; Pilot Study (PAPPA-pilot)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Onze Lieve Vrouwe Gasthuis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT01274728
First received: January 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Procedure: Percutaneous coronary intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study on PAclitaxel-eluting Balloon in Primary PCI in Amsterdam. A Clinical Evaluation, to Study the Feasibility and Safety of a Paclitaxel-eluting Balloon in Primary Percutaneous Coronary Intervention for Acute ST-elevation Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Major acute coronary event [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    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)


Secondary Outcome Measures:
  • Cross-over to bail-out stenting [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
  • Death from any cause [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Major acute coronary event [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

    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)

  • In-hospital major acute coronary event [ Time Frame: index hospitalisation ] [ Designated as safety issue: Yes ]

    Defined as, in-hospital index event:

    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)

  • Recurrent MI non-target vessel related [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularisation [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
    Target vessel revascularisation, but not target lesion revasularisation (is primary outcome measure)

  • Stroke [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
    objectified and documented by a physician

  • Stent thrombosis [ Time Frame: index hospitalisation, 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
    according tot the ARC criteria

  • NON-CABG major bleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    as in HORIZON trial

  • Hemorrhagic events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    according to TIMI bleeding classification


Biospecimen Retention:   Samples Without DNA

Biochemistry, haematology


Estimated Enrollment: 100
Study Start Date: November 2010
Groups/Cohorts Assigned Interventions
ST-elevated myocardial infarction
Those with a condition of chestpain (or equal complains) and ECG changes confirming STEMI.
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention with at least use of drug-eluting balloon and if necessary cross-over to bail-out stenting with BMS.

Detailed Description:

Multiple randomized clinical trials and pooled analyses have shown improved clinical outcomes of primary PCI when compared with fibrinolytic therapy. Primary PCI for STEMI results in greater patency of the infarct-related artery (IRA) and lower rates of death, re-infarction, and stroke when compared with fibrinolysis. The use of coronary stents has reduced the need for repeat revascularization in patients treated with primary PCI. However, in the setting of STEMI this reduction in target lesion revascularization (TLR) did not reduce re-infarction rates or both short term and long-term mortality rates. This was confirmed by a large meta-analysis by De Luca et al, using 13 randomized trials and involving 6922 patients. In studies evaluating DES versus BMS in STEMI mortality rates are similar in patients treated with BMS or DES. Although TLR rates are reduced with the use of DES, there have been concerns about long-term delay of arterial healing produced by both the Cypher DES and Taxus DES and the associated risk of late stent thrombosis. Anti-proliferative drugs in DES used to prevent neointimal hyperplasia also prevent the formation of an epithelial surface at the inner side of stents causing possible stent malapposition and potentionally late stent thrombosis. A new approach in treatment of STEMI is now available by the development of a drug eluting balloon. These DEB can be used with or without additional stent placement. Potential advantages compared to DES are a more homogeneous drug distribution, short lasting exposure and a higher local drug dose. Moreover, when no additional stent is needed, it might reduce the need for long term aggressive anti-platelet therapy in order to prevent acute, late or very late stent thrombosis. In short, DEB provides the potential advantage of delivering a anti-proliferative drug, without the disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI. The use of DEB is already tested for treatment of de novo coronary lesions and in-stent restenosis and has been shown to be a feasible and safe.In this clinical evaluation the use of the CE-marked Paclitaxel-eluting balloon with provisional stenting for STEMI will be evaluated on top of current highest standard therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Acute myocardial infarction eligible for primary PCI:

    • 20 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

Exclusion Criteria:

  • 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
  • Cardiogenic shock prior to inclusion
  • Uncertain neurological outcome e.g. resuscitation
  • Intubation/ventilation
  • Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA < 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)
  • Gastro-intestinal / urinary tract bleeding < 2 months prior to inclusion
  • Refusal to receive blood transfusion
  • Platelet number < 100.000 x 10^9/L
  • Planned major surgery within 6 weeks
  • Stent implantation < 1 month prior to inclusion
  • Expected mortality from any cause within the next 12 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274728

Contacts
Contact: R.J van der Schaaf, MD, PhD +31-20-5993440 R.J.vanderSchaaf@olvg.nl

Locations
Netherlands
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Netherlands, 1091 AC
Contact: N.S. Vos, MD    +31-20-5993440    n.s.vos@olvg.nl   
Principal Investigator: R.J. van der Schaaf, MD, PhD         
Principal Investigator: M.T. Dirksen, MD, PhD         
Sub-Investigator: F.C. van Nooijen, MD         
Sub-Investigator: N.S. Vos, MD         
Sub-Investigator: J.P.R Herrman, MD, PhD         
Sub-Investigator: T. Slagboom, MD         
Sub-Investigator: F. Kiemeneij, MD, PhD         
Sub-Investigator: M.S. Patterson, MD, PhD         
Sub-Investigator: G. Amoroso, MD, PhD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
Principal Investigator: R.J. van der Schaaf, MD, PhD Onze Lieve Vrouwe Gasthuis Amsterdam
Principal Investigator: M.T. Dirksen, MD, PhD Onze Lieve Vrouwe Gasthuis Amsterdam
Study Chair: N.S. Vos, MD Onze Lieve Vrouwe Gasthuis Amsterdam
Study Director: J.P.H. Herrman, MD, PhD Onze Lieve Vrouwe Gasthuis
  More Information

Publications:

Responsible Party: Dr. R.J. van der Schaaf, Cardiology department OLVG
ClinicalTrials.gov Identifier: NCT01274728     History of Changes
Other Study ID Numbers: wo 09.070
Study First Received: January 10, 2011
Last Updated: January 10, 2011
Health Authority: Netherlands: Medical ethics committee OLVG. Not WMO-subject.

Keywords provided by Onze Lieve Vrouwe Gasthuis:
Acute myocardial infarction
Primary percutaneous coronary intervention
Drug-eluting balloon
Bivalirudin

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014