Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
DEBATE
1 other identifier
interventional
290
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2021
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 25, 2022
August 1, 2022
1.2 years
August 22, 2022
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Follow-up coronary angiography at 12 months after the percutaneous coronary intervention
Secondary Outcomes (1)
rate of major adverse cardiac events (MACE)
6 months and 12 months after percutaneous coronary intervention
Study Arms (2)
DEB for de Novo Lesions
EXPERIMENTAL1. 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.
DES for de Novo Lesions
ACTIVE 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.
Interventions
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.
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military hospital of Tunis
Tunis, 1008, Tunisia
Related Publications (2)
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.
PMID: 35800174BACKGROUNDHajlaoui 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.
PMID: 37551532DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aymen Noamen, MD
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
- STUDY DIRECTOR
Nadhem Hajlaoui, Pr
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
- STUDY CHAIR
Wafa Fehri, Pr
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 25, 2022
Study Start
August 25, 2021
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share