NCT03260517

Brief Summary

To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
3 countries

10 active sites

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

First Submitted

Initial submission to the registry

August 10, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

August 10, 2017

Last Update Submit

September 27, 2019

Conditions

In-stent RestenosisIschemic Heart DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months

    The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.

    At 6 months follow up

Secondary Outcomes (8)

  • All deaths including cardiac death.procedure

    30 days, 6 months and 1 year after procedure

  • Target Vessel Myocardial Infarction (TVMI)

    30 days, 6 months and 1 year after procedure

  • Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods

    30 days, 6 months and 1 year after procedure

  • Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.

    30 days, 6 months and 1 year after procedure

  • 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.

    30 days, 6 months and 1 year after procedure

  • +3 more secondary outcomes

Other Outcomes (4)

  • In-stent (balloon) and in-segment LLL

    6 months post-procedure

  • In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).

    6 months post-procedure

  • In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].

    6 months post-procedure

  • +1 more other outcomes

Study Arms (1)

Treatment arm (Mdt Drug-Coated Balloon)

EXPERIMENTAL

Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.

Device: Medtronic Coronary Drug-Coated Balloon Catheter

Interventions

Medtronic Coronary Drug-Coated Balloon CatheterDEVICE

Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Treatment arm (Mdt Drug-Coated Balloon)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
  • Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.

You may not qualify if:

  • Acute Myocardial Infarction within the previous 72 hours
  • Planned treatment involves a bifurcation
  • Three vessel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Haga Ziekenhuis locatie Leyweg

The Hague, 2545 AA, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Isala Klinieken

Zwolle, 8025 AB, Netherlands

Location

Related Publications (1)

  • Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13.

    PMID: 31836635DERIVED

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 24, 2017

Study Start

October 2, 2017

Primary Completion

January 29, 2019

Study Completion

August 1, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

BE(3)IT(2)NL(5)