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

This study has been terminated.
Information provided by:
Ospedale San Donato
ClinicalTrials.gov Identifier:
First received: September 16, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
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.

Condition Intervention Phase
Stable Angina
Unstable Angina
Procedure: Paclitaxel-coated Balloon
Device: Paclitaxel-eluting Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binary restenosis defined as >50% diameter stenosis by QCA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major Adverse Cardiac Events [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 154
Study Start Date: January 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel-coated Balloon
Paclitaxel-coated Balloon Angioplasty
Procedure: Paclitaxel-coated Balloon
Other Name: Orbus
Active Comparator: Paclitaxel-eluting Stent
Paclitaxel-eluting Stent Implantation
Device: Paclitaxel-eluting Stent
Other Name: Taxus

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01204320

San Donato Hospital
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Ospedale San Donato
Study Chair: Leonardo Bolognese, MD Cardiovascular Department - San Donato Hospital
  More Information

Responsible Party: Cardiovascular Department USL 8(Leonardo Bolognese MD), Ospedale SanDonato
ClinicalTrials.gov Identifier: NCT01204320     History of Changes
Other Study ID Numbers: Arezzo003 
Study First Received: September 16, 2010
Last Updated: September 16, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale San Donato:

Additional relevant MeSH terms:
Angina, Stable
Angina, Unstable
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 26, 2016