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Percutaneous Coronary Intervention (PCI)DEBATENCT05516446

Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

A study testing DEB for de Novo Lesions and DES for de Novo Lesions in people with Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease (CAD), run by General Administration of Military Health, Tunisia at 1 site in Tunisia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DEB for de Novo Lesions and DES for de Novo Lesions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteTunisia
Study dates
25 Aug 2021to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Aymen Noamen, MD contact

0021620215773

no.aymen@gmail.com

Ahmed Ben Amara, fellow contact

0021654430166

ahmedbenikhalled@gmail.com

Tunisia1 site, 1 recruiting

  • Military hospital of Tunis

    Tunis, 1008

    Nejla Stambouli, 0021655104234, nejlastam@gmail.com

    Aymen Noamen, MD

    Recruiting

Other trials in Tunisia

About this study

Official title: 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.

Read the 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).

Being tested
DEB for de Novo Lesions, DES for de Novo Lesions
Keywords
Risk Assessment, Metals, Coronary Artery Disease, Treatment Outcome, Drug-Eluting Stents, Angioplasty, Balloon, Coronary, Randomized Controlled Trials as Topic, Coronary Restenosis
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEB for de Novo LesionsDevice

    Also called a paclitaxel drug-eluting balloon

    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.

  • DES for de Novo LesionsDevice

    Also called everolimus-eluting platinum-chromium alloy coronary stent

    The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)

Study groups in NCT05516446
Study groupRoleWhat they receive
DEB for de Novo LesionsExperimental1. 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.
Receives: Device: DEB for de Novo Lesions
DES for de Novo LesionsActive comparator1. 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.
Receives: Device: DES for de Novo Lesions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. late lumen loss (LLL)

    late lumen loss between Drug Eluting Balloon treated group and Drug Eluting Stents treated group evaluated by quantitative coronary analysis

    Measured: Follow-up coronary angiography at 12 months after the percutaneous coronary intervention

Secondary outcomes (1)

  1. rate of major adverse cardiac events (MACE)

    Major adverse cardiac event defined as the composite of myocardial infarction, target vessel revascularization and cardiac death

    Measured: 6 months and 12 months after percutaneous coronary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study start25 Aug 2021
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single-center, randomized and controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05516446
Sponsor's protocol ID
santemilitaire9
Acronym
DEBATE
Status last verified
Aug 2022
First submitted
22 Aug 2022
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhong PY, Ma Y, Shang YS, Niu Y, Bai N, Wang ZL. Efficacy of Drug-Coated Balloon Approaches for de novo Coronary Artery Diseases: A Bayesian Network Meta-Analysis. Front Cardiovasc Med. 2022 Jun 21;9:899701. doi: 10.3389/fcvm.2022.899701. eCollection 2022.

    PubMed 35800174

  • Hajlaoui N, Noamen A, Ben Amara A, Raddaoui H, Haggui A, Fehri W. Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion. Tunis Med. 2022 Decembre;100(12):824-829.

    PubMed 37551532

Questions about this trial

What is this clinical trial studying?

A study testing DEB for de Novo Lesions and DES for de Novo Lesions in people with Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease (CAD), run by General Administration of Military Health, Tunisia at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aymen Noamen, MD (0021620215773, no.aymen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

late lumen loss (LLL) (time frame: Follow-up coronary angiography at 12 months after the percutaneous coronary intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05516446, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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