NCT01632371

Brief Summary

The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

June 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

June 26, 2012

Last Update Submit

November 18, 2016

Conditions

RestenosisStable Angina PectorisAcute Coronary Syndrome

Keywords

In-stent RestenosisDrug Eluting StentPaclitaxel Coated BalloonScoring BalloonCutting BalloonAngiographic follow-upOptical coherence tomography (OCT)

Outcome Measures

Primary Outcomes (1)

  • In-segment percent diameter stenosis

    In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography

    6-8 months

Secondary Outcomes (6)

  • In-stent late lumen loss

    6-8 months

  • In-segment binary angiographic restenosis

    6-8 month

  • Death or myocardial infarction

    1 and 2 years

  • Target lesion revascularization

    1 and 2 years

  • Target lesion thrombosis

    1 and 2 years

  • +1 more secondary outcomes

Study Arms (2)

Paclitaxel Eluting Balloon + Scoring Balloon

EXPERIMENTAL

Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon

Device: Paclitaxel Eluting Balloon + Scoring Balloon

Paclitaxel Eluting Balloon

ACTIVE COMPARATOR

Paclitaxel Eluting Balloon

Device: Paclitaxel Eluting Balloon

Interventions

Paclitaxel Eluting Balloon + Scoring BalloonDEVICE

Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy

Paclitaxel Eluting Balloon + Scoring Balloon
Paclitaxel Eluting BalloonDEVICE

Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Paclitaxel Eluting Balloon

Eligibility Criteria

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

You may qualify if:

  • Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
  • In women with childbearing potential a negative pregnancy test is mandatory.

You may not qualify if:

  • Age \< 18 years
  • Cardiogenic shock
  • Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  • Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome
  • Therapy including Lovastatin, Ciclosporin, Terfenadine, Midazolam, or Ondansetron
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, Bavaria, 80636, Germany

Location

1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

  • Kufner S, Joner M, Schneider S, Tolg R, Zrenner B, Repp J, Starkmann A, Xhepa E, Ibrahim T, Cassese S, Fusaro M, Ott I, Hengstenberg C, Schunkert H, Abdel-Wahab M, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 4 Investigators. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1332-1340. doi: 10.1016/j.jcin.2017.04.024.

    PMID: 28683939DERIVED

MeSH Terms

Conditions

Angina, StableAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Munich

    STUDY CHAIR

  • Robert Byrne, MB PhD

    Deutsches Herzzentrum Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

July 2, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

November 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

DE(2)