Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-10-31

Brief Summary

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This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.

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Detailed Description

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Although the use of drug-eluting stents (DES) has reduced in-stent restenosis when compared to bare metal stents (BMS) and decreased the incidence of adverse clinical events (1-2), DES therapy is limited by delayed arterial healing, late acquired malapposition and neo-atherosclerosis leading to an increased risk of late stent thrombosis and late restenosis (3-4). Conceptually, a permanent stent inhibits advantageous vascular remodeling and durable polymer provokes excessive inflammation (5). Non-stent based local drug delivery using paclitaxel-coated balloon has emerged as a new clinical treatment alternative by maintaining the anti-proliferative properties of DES (6). There is limited data on the efficacy of Drug Coated Balloon (DCB) treatment for de novo coronary lesions when compared to BMS. To avoid the risk of abrupt closure of target lesion after balloon angioplasty, a reliable predictor of coronary flow is necessary especially in de novo lesions of major coronary arteries. Therefore, using fractional flow reserve (FFR) after angioplasty as a good indicator of immediate functional improvement and reduced restenosis (7), the aim of this study is to assess the efficacy of DCB treatment compared to BMS in patients with de novo coronary artery lesions.

Patients with de novo coronary artery lesions with \> 50% stenosis in a single vessel and at high risk of bleeding with the inability to tolerate dual antiplatelet therapy (DAPT) will be included in this trial. Patients will undergo balloon angioplasty and if the FFR post balloon angioplasty is \> 0.80, they will be randomized to receive either DCB or BMS. Patients will receive Quantitative Coronary Angiography (QCA) analysis at 9 months follow-up. Endpoints are late luminal loss at 9 months and major adverse events including arterial thrombosis at 1, 9 and 12 months and these endpoints will be compared between DCB and BMS groups.

Conditions

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Stable Angina Unstable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Drug Coated Balloon

PCB (SeQuent Please®, paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany)

Group Type EXPERIMENTAL

Drug Coated Balloon

Intervention Type DEVICE

If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.

Bare Metal Stent

BMS (Vision®)

Group Type ACTIVE_COMPARATOR

Bare Metal Stent

Intervention Type DEVICE

BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.

Interventions

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Drug Coated Balloon

If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.

Intervention Type DEVICE

Bare Metal Stent

BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stable Angina and Unstable angina
* single de novo coronary artery lesions in a single vessel with \> 50% diameter stenosis with a reference diameter \> 2.75mm
* Unexplained anemia
* Atrial fibrillation with CHADSVASC \> or equal to 1
* Patients awaiting for non cardiac surgery within a year
* History of massive hemorrhage requiring transfusion
* History of upper GI bleeding
* Malignancy
* Poor compliance with medication

Exclusion Criteria

* STEMI/NSTEMI within the preceding 72 hours
* Multivessel disease, chronic total occlusion, long lesions and left main disease
* heart failure with ejection fraction \< 35% and/or cardiogenic shock
* Previous history of or planned coronary artery bypass grafting
* life expectancy of less than 1 year

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No