Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent (DEBATE)

August 23, 2022 updated by: General Administration of Military Health, Tunisia

Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent

Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group and Everolimus platinum chrome stent treated group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Drug eluting stents (DES) leave a permanent metal implant that interferes with vasomotion, endothelial function and vascular remodeling. the rigid structure and the pharmacological properties of DES could overcome acute complications related to balloon dilation and late complications related to in-stent restenosis. However, they do not restore normal arterial function after the procedure.

Drug eluting balloons (DEB) offer an alternative to the implantation of a durable material. They release a transient antiproliferative drug. They promise potential advantages over DES as:

  • an ad integrum restitution of the endothelium and its vasomotor properties.
  • a reduction of late thrombosis risk.
  • the possibility of grafting on the treated segment.
  • avoid the problems of side-branch trapped in the treatment of bifurcations.
  • improve the profitability of non-invasive imaging (coroscanner, magnetic resonance imaging) during patient follow-up.

DEB is validated for the treatment of in-stent restenosis, especially focal and on small caliber arteries. The use of DEB in de novo lesions has been the subject of several studies. This therapeutic option should be evaluated in the Tunisian context The aim of this clinical trial is to compare the results of angioplasty by DEB (SEQUENT PLEASE) versus last generation DES: coronary stent system in platinum chromium alloy with everolimus elution (Promus Premier and Promus Elite) The Primary endpoint: late lumen loss at 12 months. The Secondary endpoint: the major cardiovascular event rate (MACE).

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • 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

  • Tunisia
      • Tunis, Tunisia, 1008
        • Recruiting
        • Military Hospital of Tunis
        • Contact:

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

Description

Inclusion Criteria:

  • Patients with silent ischemia, stable angina, unstable angina, or non-Q wave myocardial infarction.
  • a de Novo lesion on a never treated native artery.
  • A reference artery diameter between 2 mm and 4 mm.

Non-inclusion criteria

  • Patients with STEMI in the acute phase or presenting a cardiogenic shock.
  • Patients with an allergy or a contraindication to double anti-platelet aggregation.
  • Pre-menopausal patients not using regularly an oral contraceptives or breast-feeding .
  • Patients with severe comorbidity or with an estimated survival of less than 12 months.
  • Dissected lesions or spontaneous dissections other than grade A or B requiring DES angioplasty.
  • In-stent restenosis.
  • Thrombotic lesions.

Exclusion Criteria:

  • None

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
Intervention / Treatment
EXPERIMENTAL: DEB for de Novo Lesions
  1. Preparation of the lesion by pre-dilation or another technique using a balloon undersized by 0.5 mm compared to the reference diameter of the artery and, if necessary, by a second balloon with a balloon/artery ratio of 0.8-1 inflated to 16-18 atm for best results.
  2. when obtaining a stent-like result and in the absence of a major dissection less than grade C, a flow TIMI less than 3 and a residual stenosis of more than 30%, an angioplasty by a drug eluting balloon will be performed for an inflation of 30 seconds at 8-10 atm.
  3. Otherwise, an angioplasty using a drug eluting stent will be proceeded.

  4. Before removing the intracoronary guide, the operator will evaluate by Quantitative Coronary Arteriography (QCA)

    • The post-procedural TIMI flow.
    • the minimal post-procedural luminal diameter in mm.
Device: DEB for de Novo Lesions
The surface of the SeQuent® Please NEO balloon is coated with Paclitaxel at a concentration of 3 μg Paclitaxel per mm² of balloon surface. The matrix composed of Paclitaxel and Iopromide (Paccocath technology) allows homogeneous release of the active ingredient through the vessel surface.
Other Names:
  • a paclitaxel drug-eluting balloon
ACTIVE_COMPARATOR: DES for de Novo Lesions
  1. The preparation of the lesion and the post dilation will be left to the discretion of the operator.
  2. Angioplasty with Drug eluting balloon after pre dilatation will be performed.

  3. Before removing the intracoronary guide, the operator will evaluate by Quantitative Coronary Arteriography (QCA)

    • The post-procedural TIMI flow.
    • the minimal post-procedural luminal diameter in mm.
Device: DES for de Novo Lesions
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)
Other Names:
  • everolimus-eluting platinum-chromium alloy coronary stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late lumen loss (LLL)
Time Frame: Follow-up coronary angiography at 12 months after the percutaneous coronary intervention
late lumen loss between Drug Eluting Balloon treated group and Drug Eluting Stents treated group evaluated by quantitative coronary analysis
Follow-up coronary angiography at 12 months after the percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of major adverse cardiac events (MACE)
Time Frame: 6 months and 12 months after percutaneous coronary intervention
Major adverse cardiac event defined as the composite of myocardial infarction, target vessel revascularization and cardiac death
6 months and 12 months after percutaneous coronary intervention

Collaborators and Investigators

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

Sponsor

General Administration of Military Health, Tunisia

Collaborators

B. Braun Medical International Trading Company Ltd.

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 (ACTUAL)

August 25, 2021

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (ACTUAL)

August 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • santemilitaire9

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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