NCT01489449

Brief Summary

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

November 27, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5.6 years

First QC Date

November 27, 2011

Last Update Submit

May 2, 2023

Conditions

Coronary Heart DiseaseNSTEMI

Keywords

drug coated balloonNSTEMI

Outcome Measures

Primary Outcomes (1)

  • MACE

    MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization

    9 months

Secondary Outcomes (6)

  • Stent thrombosis (ARC

    9 months, 3 years, 5 years

  • Mortality (cardiac and non-cardiac)

    9 months, 3 years, 5 years

  • Reinfarction

    9 months, 3 years, 5 years

  • target lesion revascularization

    9 months, 3 years, 5 years

  • target vessel revascularization

    9 months, 3 years, 5 years

  • +1 more secondary outcomes

Study Arms (2)

Stent

PLACEBO COMPARATOR

Stent Implantation (DES or BMS), no further treatment

Device: Stent

DCB

ACTIVE COMPARATOR

"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection

Combination Product: SeQuent(R) Please coated balloon

Interventions

StentDEVICE

bare metal stent implantation, any bare metal stent is allowed from different companies

Stent
SeQuent(R) Please coated balloonCOMBINATION_PRODUCT

Angioplasty with Drug coated balloon (DCB)

Also known as: SeQuent(R) Please
DCB

Eligibility Criteria

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

You may qualify if:

  • NSTEMI with
  • Ischemic symptoms (angina pectoris) \> 30 minutes
  • Last symptoms within 72 hours before randomization
  • Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
  • age \> 18 years
  • Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)

You may not qualify if:

  • Cardiogenic shock
  • ST-elevation myocardial infarction
  • No identifiable culprit lesion, Indication for acute bypass surgery
  • Comorbidity with limited life expectancy \< 9-12 months
  • Contraindication for treatment with heparin, ASA and thienopyridines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg/Saar, Saarland, 66421, Germany

Location

Related Publications (1)

  • Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Bohm M, Degenhardt R, Mahfoud F, Lauer B. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020 Apr 17;15(17):1527-1533. doi: 10.4244/EIJ-D-19-00723.

    PMID: 31659986DERIVED

MeSH Terms

Conditions

Coronary DiseaseNon-ST Elevated Myocardial Infarction

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Bruno Scheller, MD

    Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2011

First Posted

December 9, 2011

Study Start

December 1, 2012

Primary Completion

June 23, 2018

Study Completion

June 23, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

DE(1)