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TerminatedNCT01204320COMPACT-ISRUpdated Sep 17, 2010

A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)

A Phase 4 interventional study of Paclitaxel-coated Balloon and Paclitaxel-eluting Stent in Stable Angina and Unstable Angina, sponsored by Ospedale San Donato. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-17.

Sponsored by Ospedale San Donato · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.

Read the detailed description

The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

02

Conditions studied

  • Stable Angina
  • Unstable Angina

Keywords

  • Restenosis
  • POBA
  • Stenting
  • Paclitaxel
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's planned enrollment of 154 is above the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Ospedale San Donato is the lead sponsor of 25 studies on the registry; 1 is 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

Inclusion criteria

  • informed consent
  • >18y
  • Stable Angina or Unstable Angina
  • Single restenotic lesion in a previously stented coronary artery

Exclusion criteria

Exclusion Criteria:

  • Acute Myocardial Infarction within 72h
  • Serum Creatinine>2.0 mg/dL
  • Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
  • Contraindications to contrast media
  • Life expectancy \< 2y
  • Target Lesion length > 30mm
  • Target Lesion diameter \<= 2.5 mm
  • Target stenosis \< 70%
  • Massive Calcifications in the target segment
  • Evidence of intra-coronary thrombus
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    Paclitaxel-coated Balloon

    Paclitaxel-coated Balloon Angioplasty

    Procedure: Paclitaxel-coated Balloon

  • Active comparator
    Paclitaxel-eluting Stent

    Paclitaxel-eluting Stent Implantation

    Device: Paclitaxel-eluting Stent

Interventions

  • ProcedurePaclitaxel-coated Balloon

    POBA

    Also known as: Orbus

  • DevicePaclitaxel-eluting Stent

    Stenting

    Also known as: Taxus

06

What researchers measure

Primary outcomes

  1. Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis

    Time frame: 6 months

Secondary outcomes

  1. Binary restenosis defined as >50% diameter stenosis by QCA

    Time frame: 6 months

  2. Major Adverse Cardiac Events

    Time frame: 6, 12 months

  3. Target Lesion Revascularization

    Time frame: 6, 12 months

07

Study locations

1 site
  • San Donato Hospital
    Arezzo, AR 52100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01204320
Lead sponsor
Ospedale San Donato
First posted
Sep 17, 2010
Start date
Jan 2008
Primary completion
Jan 2010 (estimated)
Last update
Sep 17, 2010

Study contacts

Leonardo Bolognese, MD
study chair · Cardiovascular Department - San Donato Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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