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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204320
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ospedale San Donato
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Binary restenosis defined as >50% diameter stenosis by QCA [ Time Frame: 6 months ]
  • Major Adverse Cardiac Events [ Time Frame: 6, 12 months ]
  • Target Lesion Revascularization [ Time Frame: 6, 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cardiovascular Department USL 8(Leonardo Bolognese MD), Ospedale SanDonato
ClinicalTrials.gov Identifier: NCT01204320     History of Changes
Other Study ID Numbers: Arezzo003
First Submitted: September 16, 2010
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
Last Verified: October 2009

Keywords provided by Ospedale San Donato:
Restenosis
POBA
Stenting
Paclitaxel

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