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

April 2, 2019 updated by: Prof Eun-Seok Shin, MD. PhD., Ulsan University Hospital

Randomized Controlled Trial of Drug Coated Balloon Compared to Bare Metal Stent Using FFR-guidance for the Treatment of de Novo Coronary Artery Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Patients at high risk of bleeding and whom cannot tolerate dual antiplatelet therapy for > 1 month are inclusion criteria for the study and are listed here:
  • 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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Coated Balloon
PCB (SeQuent Please®, paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany)
Device: 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.
Active Comparator: Bare Metal Stent
BMS (Vision®)
Device: Bare Metal Stent
BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE) (death, myocardial infarction, repeat revascularization, recurrent ischemic symptoms)
Time Frame: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Arterial thrombosis
Time Frame: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Any stent thrombosis - acute, subacute/late stent thrombosis
Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Fractional Flow Reserve
Time Frame: Post procedure (up to 1 hour) and 9 months
FFR is the ratio of the pressure measured at the distal portion of the target lesion and the aortic ostium at maximal hyperemia
Post procedure (up to 1 hour) and 9 months

Collaborators and Investigators

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

Sponsor

Ulsan University Hospital

Collaborators

Seoul National University Hospital

Investigators

  • Principal Investigator: Eun-Seok Shin, M.D., PhD., Ulsan University Hospital

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)

April 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 25, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111 (Prima Psychiatry internal research fund)

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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