NCT02528474

Brief Summary

Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 31, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

March 29, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

July 31, 2015

Last Update Submit

March 27, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Neointimal thickness & area

    measured by OCT analysis

    9 months

Study Arms (2)

Pantera Lux

EXPERIMENTAL
Device: balloon angioplasty with Pantera Lux

SeQuent Please

ACTIVE COMPARATOR
Device: balloon angioplasty with SeQuent Please

Interventions

balloon angioplasty with Pantera LuxDEVICE

Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.

Pantera Lux
balloon angioplasty with SeQuent PleaseDEVICE

Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.

SeQuent Please

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 19 years old
  • Patients eligible for percutaneous coronary intervention
  • Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent
  • Reference vessel diameter of target lesion ≥2.5 mm

You may not qualify if:

  • Cardiogenic shock
  • Bifurcation lesion or totally occluded lesion
  • Unprotected left main trunk lesion
  • Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel
  • Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
  • Pregnant women or women with potential childbearing
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed content

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 19, 2015

Study Start

September 30, 2015

Primary Completion

April 20, 2017

Study Completion

April 20, 2017

Last Updated

March 29, 2019

Record last verified: 2019-02

Locations

KR(1)