NCT01204320

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
Last Updated

September 17, 2010

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

September 16, 2010

Last Update Submit

September 16, 2010

Conditions

Stable AnginaUnstable Angina

Keywords

RestenosisPOBAStentingPaclitaxel

Outcome Measures

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

    6 months

Secondary Outcomes (3)

  • Binary restenosis defined as >50% diameter stenosis by QCA

    6 months

  • Major Adverse Cardiac Events

    6, 12 months

  • Target Lesion Revascularization

    6, 12 months

Study Arms (2)

Paclitaxel-coated Balloon

EXPERIMENTAL

Paclitaxel-coated Balloon Angioplasty

Procedure: Paclitaxel-coated Balloon

Paclitaxel-eluting Stent

ACTIVE COMPARATOR

Paclitaxel-eluting Stent Implantation

Device: Paclitaxel-eluting Stent

Interventions

Paclitaxel-coated BalloonPROCEDURE

POBA

Also known as: Orbus
Paclitaxel-coated Balloon
Paclitaxel-eluting StentDEVICE

Stenting

Also known as: Taxus
Paclitaxel-eluting Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Donato Hospital

Arezzo, AR, 52100, Italy

Location

MeSH Terms

Conditions

Angina, StableAngina, Unstable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonardo Bolognese, MD

    Cardiovascular Department - San Donato Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Last Updated

September 17, 2010

Record last verified: 2009-10

Locations

IT(1)