JACTAX LD Drug Eluting Stent Trial

February 28, 2017 updated by: Boston Scientific Corporation

A Clinical Trial Comparing the Performance of the JACTAX LD DES With the TAXUS™ Libertè™ DES

Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.

Study Overview

Status

Status

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

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

The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.

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.
Interventional

Enrollment (Actual)

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.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Germany
      • Bonn, Germany
        • Universitatsklinikum Bonn
      • Frankfurt, Germany
        • Cardiovascular Center Sankt Katharinen
      • Hamburg, Germany
        • Hamburg University Cardiovascular Center
      • Siegburg, Germany
        • Helios Klinikum
      • Trier, Germany
        • Krankenhaus der Barmherzigen Brüder

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

Description

General Inclusion Criteria:

  1. Patient is ≥ 18 years of age
  2. Patient with coronary artery disease, eligible for percutaneous coronary intervention (PCI)
  3. Patient demonstrates a LVEF of ≥ 25%
  4. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect.

Angiographic Inclusion Criteria

  1. Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
  2. The target lesion can be treated with a maximum of one stent, with adequate coverage onto the healthy tissue, as specified in visual estimate guidelines. Maximum lesion length is 20mm.
  3. The reference vessel diameter is between 2.75mm and 3.5mm
  4. Study lesion diameter stenosis is ≥70% (visual estimate) and <100% and a TIMI flow >1.
  5. Study lesion has been successfully pre-dilated
  6. Patients enrolled for treatment may demonstrate multiple lesions in target vessel. However lesions must be covered completely by one study stent.
  7. Patient must have no more than two lesions requiring treatments. These lesions must be in different vessel distributions. For example, if the target lesion is in the LAD, then the non target lesion must be present in either the circumflex or RCA. The non-study lesion may not be in a branch vessel or distal to the target vessel location.
  8. The non target lesion must be successfully treated prior to the treatment of the target lesion. The non target lesion must be treated with a TAXUS paclitaxel eluting stent or a bare metal stainless steel stent.

General Exclusion Criteria:

  1. The patient has a life expectancy of less than 24 months due to another medical condition
  2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
  3. Patient exhibits cardiogenic shock (systolic pressure <80mmHg and PCWP >20mmHg or cardiac index <1.8 liters/minute/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80mmHg) for any time within 24 hours prior to index procedure
  4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or 177 umol/l)
  5. Planned cardiac surgery procedure <= 9 months post index procedure
  6. Patient demonstrates evidence of myocardial infarction (elevated CK, CKMB or Troponin) within 72 hours prior to the index procedure and/or CK >2X local lab's ULN, unless CK-MB is < 2X ULN
  7. Patient exhibits acute ST segment elevation MI within 72 hours prior to the index procedure
  8. CVA including stroke or TIA within previous 3 months
  9. Patient demonstrates evidence of leukopenia
  10. Patient demonstrates evidence of thrombocytopenia or thrombocytosis
  11. Patient is contraindicated to ASA, clopidogrel or ticlopidine
  12. Patient is currently taking warfarin or possibility of treatment with warfarin during the following 6 months post index procedure
  13. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
  14. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
  15. Patient has received a drug eluting stent within 12 months prior to planned index procedure
  16. Previous or planned treatment with intravascular brachytherapy in target vessel
  17. Known allergy to stainless steel
  18. Male or female with known intention to procreate within 3 months after the index procedure
  19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure or lactating or intends to become pregnant during the 9 months post index procedure

Angiographic Exclusion Criteria

  1. Evidence of probable or definite thrombus of the study vessel, based on angiography or IVUS
  2. Study lesion is totally occluded (TIMI flow <= 1)either at baseline or before predilatation
  3. Study lesion or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
  4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
  5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a > 60 degree bend in the vessel
  6. Study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
  7. Left main coronary artery disease (stenosis >50%) whether protected or unprotected
  8. Target lesion length >20mm based on visual estimate by operator
  9. Target vessel diameter >3.5mm based on visual estimate by operator
  10. Target vessel diameter <2.75 mm based on visual estimate by operator
  11. Pre-treatment of the target lesion (excluding predilation) with another interventional device

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: I
JACTAX LD DES
Device: JACTAX LD DES
Drug Eluting Stent
Active Comparator: II
TAXUS™ Libertè™ DES
Device: TAXUS™ Libertè™ DES
Drug Eluting Stent

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
Time Frame
MACE rate at 9 months
Time Frame: 9 months
9 months

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.
Boston Scientific Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Labcoat, Ltd.

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: Eberhard Grube, Elizabeth Hospital, Essen Germany

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.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 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).
September 16, 2008

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.
September 16, 2008

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.
September 18, 2008

Study Record Updates

Last Update Posted (Actual)

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.
March 1, 2017

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.
February 28, 2017

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.
February 1, 2017

More Information

Terms related to this study

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.
  • LBCT-H02-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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