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

This study has been terminated.
Sponsor:
Information provided by:
Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01204320
First received: September 16, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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:

MedlinePlus related topics: Angina Angioplasty
Drug Information available for: Paclitaxel
U.S. FDA Resources

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
POBA
Other Name: Orbus
Active Comparator: Paclitaxel-eluting Stent
Paclitaxel-eluting Stent Implantation
 Device: Paclitaxel-eluting Stent
Stenting
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204320

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

No publications provided

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:
Restenosis
POBA
Stenting
Paclitaxel

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013