NCT01127958

Brief Summary

The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

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

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

10.1 years

First QC Date

May 18, 2010

Last Update Submit

February 16, 2017

Conditions

In-stent Restenosis

Keywords

In-stent restenosisMinimal lumen diameterDrug eluting balloonDrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI

    The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience™ Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months.

    6 month's after PCI

Secondary Outcomes (3)

  • In-stent and in-segment percent Diameter Stenosis

    6 months

  • In-stent and in-segment Angiographic binary restenosis

    6 months

  • Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm

    6 months

Study Arms (2)

SeQuent Please

ACTIVE COMPARATOR

PCI with drug-eluting balloon

Device: PCI with a drug-eluting balloon

Xience Prime

ACTIVE COMPARATOR

PCI with a drug-eluting stent

Device: PCI with a drug-eluting stent

Interventions

PCI with a drug-eluting balloonDEVICE

PCI with a drug-eluting balloon for in-stent restenosis

SeQuent Please
PCI with a drug-eluting stentDEVICE

PCI with a drug-eluting stent for in-stent restenosis

Xience Prime

Eligibility Criteria

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

You may qualify if:

  • Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
  • Restenosis of any type of stent; all drug-eluting stents or bare metal stents
  • Restenosis must be present \> 50% in-stent and \< 5 mm out of the stent
  • A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
  • Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
  • Amendable to dual antiplatelet treatment for the duration of 1 year
  • Patients must be ≥ 18 years of age
  • Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives
  • Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)
  • Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years

You may not qualify if:

  • Life expectancy less than one year
  • Severe renal insufficiency (glomerular filtration rate \<30mL/min), with exception of of patients with renal dialysis
  • STEMI
  • Restenosis in a biodegradable stent
  • Restenosis in a non CE marked stent
  • Requirement for PCI in the same vessel or expected in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Academisch Medisch Centrum

Amsterdam, 1105AZ, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

VUmc

Amsterdam, Netherlands

Location

Tergooi Ziekenhuizen

Blaricum, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Albert Schweitzer ziekenhuis

Dordrecht, 3300AK, Netherlands

Location

UMC St Radboud

Nijmegen, 6500HB, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Jan Baan, Dr

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    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
J. Baan, MD, PhD

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 21, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

NL(8)