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

Unstable Angina Clinical Trial

— COMPACT-ISR  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01204320
• Other study ID #: Arezzo003
• 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. 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

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Stable Angina
• Unstable Angina

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