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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01204320
Other study ID # Arezzo003
Secondary ID
Status Terminated
Phase Phase 4
First received September 16, 2010
Last updated September 16, 2010
Start date January 2008

Study information

Verified date October 2009
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 154
Est. completion date
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Procedure:
Paclitaxel-coated Balloon
POBA
Device:
Paclitaxel-eluting Stent
Stenting

Locations

Country Name City State
Italy San Donato Hospital Arezzo AR

Sponsors (1)

Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis 6 months No
Secondary Binary restenosis defined as >50% diameter stenosis by QCA 6 months No
Secondary Major Adverse Cardiac Events 6, 12 months Yes
Secondary Target Lesion Revascularization 6, 12 months Yes
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