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CompletedNCT01495533Updated Apr 27, 2023

Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

A Phase 3 interventional study of uncoated AngioSculpt(R) and Drug coated AngioSculpt(R) in In-stent Arterial Restenosis, sponsored by University Hospital, Saarland. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by University Hospital, Saarland · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Read the detailed description

Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.

02

Conditions studied

  • In-stent Arterial Restenosis
03

In context

Lead sponsor

University Hospital, Saarland is the lead sponsor of 43 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >18 years of age
  • clinical evidence of stable or unstable angina or a positive functional study
  • patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)

Exclusion criteria

Exclusion Criteria:

  • acute myocardial infarction within the past 72 hours
  • chronic renal insufficiency with serum creatinine levels >2.0 mg per deciliter%
  • known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
  • concomitant medical illness associated with a life-expectancy of less than two years
  • stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    uncoated AngioSculpt(R)

    Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

    Device: uncoated AngioSculpt(R)

  • Active comparator
    drug coated AngioSculpt(R)

    Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

    Combination Product: Drug coated AngioSculpt(R)

Interventions

  • Deviceuncoated AngioSculpt(R)

    Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

  • Combination productDrug coated AngioSculpt(R)

    Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

06

What researchers measure

Primary outcomes

  1. late lumen loss in-segment

    angiographic late lumen loss in-segment assessed by quantitative coronary angiography

    Time frame: 6 months

Secondary outcomes

  1. Procedural Success

    \<50% final DS and the absence of in-hospital MACE

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days

  2. Major adverse cardiovascular events

    the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)

    Time frame: 6 months

07

Study locations

3 sites
  • Danta Pazzanese Heart Institute
    São Paulo, Brazil
  • Internal Medicine III, UKS
    Homburg Saar, 66421, Germany
  • Herzzentrum Leipzig
    Leipzig, Germany
08

References and documents

Publications

  • Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2. PubMed 26331782 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2011 to primary completion in Dec 2013, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2011
First posted
Dec 20, 2011
StartActual
Dec 2011
Primary completionActual
Dec 2013
CompletionActual
Jul 2014
Last update
Apr 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01495533
Lead sponsor
University Hospital, Saarland
Responsible party
Sponsor
First posted
Dec 20, 2011
Start date
Dec 2011
Primary completion
Dec 2013
Completion
Jul 2014
Last update
Apr 27, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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