Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

January 9, 2018 updated by: Aesculap AG

SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

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.

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.
202

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

  • Poland
      • Katowice, Poland, 40-635
        • Upper Silesian Heart Center

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

Inclusion Criteria:

  • Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
  • Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
  • One lesion treated with the study device

Exclusion Criteria:

  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
  • Inability to provide informed consent
  • Currently participating in another trial before reaching the primary endpoint
  • Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
  • Acute or recent myocardial infarction
  • left ventricular ejection fraction (LVEF) < 30 %
  • Stroke or transient ischemic attack within 6 months
  • Stented segment longer than 23 mm
  • Vessel diameter of less than 2,5 mm
  • Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion

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
  • Masking: SINGLE

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: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)
  • standard techniques will be used
  • maximal vasodilatation after nitro application
  • baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
  • 6 French guiding catheter at least
  • target lesion will be crossed with standard guidewire
  • direct stenting at the discretion of the investigator
  • if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
  • full lesion coverage will be ensured (with one or more stents)
  • only insert assigned stent type
  • BMS needs to be fully embedded in vessel wall
  • post-dilation with high pressure is required before treatment with DEB
  • DEB will be inflated with nominal pressure (balloon equates to vessel diameter)
  • length of DEB should exceed the BMS by 2-3 mm on each side
  • if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)
Other Names:
  • DEB
  • Coroflex Blue
  • Cobalt Chromium stent
  • BMS
  • SeQuent Please
  • Paclitaxel-coated Balloon Catheter
ACTIVE_COMPARATOR: Drug Eluting Stent (DES)
Device: Coroflex Please (DES)
  • standard techniques will be used
  • maximal vasodilatation after nitro application
  • baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
  • 6 French guiding catheter at least
  • target lesion will be crossed with standard guidewire
  • direct stenting at the discretion of the investigator
  • if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
  • full lesion coverage will be ensured (with one or more stents)
  • only insert assigned stent type
Other Names:
  • DES
  • Coroflex Please
  • Paclitaxel-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
Measure Description
Time Frame
Major adverse cardiac events (MACE) - target vessel failure (TVF)
Time Frame: 9 months
consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population
9 months

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
Major adverse cardiac events (MACE)
Time Frame: 1 year
defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis
1 year
in-stent binary restenosis
Time Frame: 9 months
defined as >= 50 % diameter stenosis (% DS)
9 months
Angiographic and clinical stent thrombosis
Time Frame: 30 days
30 days
Angiographic and clinical stent thrombosis
Time Frame: 6 months
6 months
Angiographic and clinical stent thrombosis
Time Frame: 9 months
9 months
Angiographic and clinical stent thrombosis
Time Frame: 1 year
1 year
Angiographic and clinical stent thrombosis
Time Frame: 2 years
2 years
Angiographic and clinical stent thrombosis
Time Frame: 3 years
3 years
In-stent and in-segment minimal luminal diameter (MLD)
Time Frame: 9 months
9 months
In-segment percent diameter stenosis (%DS)
Time Frame: 9 months
9 months
In-stent and in-segment late luminal loss
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.
Aesculap AG

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: Paweł E. Buszman, MD, PhD, American Heart of Poland, Katowice

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.
August 1, 2010

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.
February 1, 2013

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, 2015

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).
July 20, 2010

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.
July 20, 2010

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.
July 21, 2010

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.
January 10, 2018

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 9, 2018

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, 2018

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.
  • SEQUENT 1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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