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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01204320

Acronym

COMPACT-ISR

Enrollment

154

Registered

2010-09-17

Start date

2008-01-31

Completion date

Unknown

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina, Unstable Angina

Keywords

Restenosis, POBA, Stenting, Paclitaxel

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.

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.

Interventions

PROCEDUREPaclitaxel-coated Balloon

POBA

DEVICEPaclitaxel-eluting Stent

Stenting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Binary restenosis defined as >50% diameter stenosis by QCA	6 months
Major Adverse Cardiac Events	6, 12 months
Target Lesion Revascularization	6, 12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026