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

January 10, 2011 updated by: Onze Lieve Vrouwe Gasthuis

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Recruiting
        • Onze Lieve Vrouwe Gasthuis
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major acute coronary event
Time Frame: 1 month

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-over to bail-out stenting
Time Frame: 1, 6 and 12 months
1, 6 and 12 months
Death from any cause
Time Frame: 1, 6 and 12 months
1, 6 and 12 months
Major acute coronary event
Time Frame: 6 and 12 months

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)
6 and 12 months
In-hospital major acute coronary event
Time Frame: index hospitalisation

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)
index hospitalisation
Recurrent MI non-target vessel related
Time Frame: 1, 6 and 12 months
1, 6 and 12 months
Target vessel revascularisation
Time Frame: 1, 6 and 12 months
Target vessel revascularisation, but not target lesion revasularisation (is primary outcome measure)
1, 6 and 12 months
Stroke
Time Frame: 1, 6 and 12 months
objectified and documented by a physician
1, 6 and 12 months
Stent thrombosis
Time Frame: index hospitalisation, 1, 6 and 12 months
according tot the ARC criteria
index hospitalisation, 1, 6 and 12 months
NON-CABG major bleeding
Time Frame: 1 month
as in HORIZON trial
1 month
Hemorrhagic events
Time Frame: 1 month
according to TIMI bleeding classification
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (ESTIMATE)

January 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wo 09.070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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