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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Onze Lieve Vrouwe Gasthuis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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