NCT02456402

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

May 18, 2015

Last Update Submit

April 2, 2019

Conditions

Stable AnginaUnstable Angina

Outcome Measures

Primary Outcomes (1)

  • Late luminal loss

    9 months

Secondary Outcomes (3)

  • Major adverse cardiovascular events (MACE) (death, myocardial infarction, repeat revascularization, recurrent ischemic symptoms)

    Post procedure (up to 1 hour), 1 month, 9 months and 12 months

  • Arterial thrombosis

    Post procedure (up to 1 hour), 1 month, 9 months and 12 months

  • Fractional Flow Reserve

    Post procedure (up to 1 hour) and 9 months

Study Arms (2)

Drug Coated Balloon

EXPERIMENTAL

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

Device: Drug Coated Balloon

Bare Metal Stent

ACTIVE COMPARATOR

BMS (Vision®)

Device: Bare Metal Stent

Interventions

Drug Coated BalloonDEVICE

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.

Drug Coated Balloon
Bare Metal StentDEVICE

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

Bare Metal Stent

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (8)

  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PMID: 12050336BACKGROUND

  • Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

    PMID: 14523139BACKGROUND

  • Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

    PMID: 16814667BACKGROUND

  • Nakazawa G, Vorpahl M, Finn AV, Narula J, Virmani R. One step forward and two steps back with drug-eluting-stents: from preventing restenosis to causing late thrombosis and nouveau atherosclerosis. JACC Cardiovasc Imaging. 2009 May;2(5):625-8. doi: 10.1016/j.jcmg.2009.01.011. No abstract available.

    PMID: 19442951BACKGROUND

  • Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.

    PMID: 24058078BACKGROUND

  • Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

    PMID: 15302790BACKGROUND

  • Bech GJ, Pijls NH, De Bruyne B, Peels KH, Michels HR, Bonnier HJ, Koolen JJ. Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation. 1999 Feb 23;99(7):883-8. doi: 10.1161/01.cir.99.7.883.

    PMID: 10027810BACKGROUND

  • Shin ES, Lee JM, Her AY, Chung JH, Eun Lee K, Garg S, Nam CW, Doh JH, Koo BK. Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions. Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755.

    PMID: 31009399DERIVED

MeSH Terms

Conditions

Angina, StableAngina, Unstable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eun-Seok Shin, M.D., PhD.

    Ulsan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 28, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

KR(1)