Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
NCT ID: NCT05516446
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
290 participants
INTERVENTIONAL
2021-08-25
2022-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
DES for de Novo Lesions
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)
Interventions
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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.
DES for de Novo Lesions
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a de Novo lesion on a never treated native artery.
* A reference artery diameter between 2 mm and 4 mm.
* 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
18 Years
ALL
No
Sponsors
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B. Braun Medical International Trading Company Ltd.
INDUSTRY
General Administration of Military Health, Tunisia
NETWORK
Responsible Party
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Principal Investigators
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Aymen Noamen, MD
Role: PRINCIPAL_INVESTIGATOR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Nadhem Hajlaoui, Pr
Role: STUDY_DIRECTOR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Wafa Fehri, Pr
Role: STUDY_CHAIR
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Locations
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Military hospital of Tunis
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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santemilitaire9
Identifier Type: -
Identifier Source: org_study_id
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