Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01495533

Enrollment

Registered

2011-12-20

Start date

2011-12-31

Completion date

2014-07-31

Last updated

2023-04-27

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

Conditions

In-stent Arterial Restenosis

Brief summary

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Detailed description

Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.

Interventions

DEVICEuncoated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

COMBINATION_PRODUCTDrug coated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \>18 years of age * clinical evidence of stable or unstable angina or a positive functional study * patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)

Exclusion criteria

* acute myocardial infarction within the past 72 hours * chronic renal insufficiency with serum creatinine levels \>2.0 mg per deciliter% * known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication * concomitant medical illness associated with a life-expectancy of less than two years * stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%

Design outcomes

Primary

Measure	Time frame	Description
late lumen loss in-segment	6 months	angiographic late lumen loss in-segment assessed by quantitative coronary angiography

Secondary

Measure	Time frame	Description
Procedural Success	participants will be followed for the duration of hospital stay, an expected average of 2 days	\<50% final DS and the absence of in-hospital MACE
Major adverse cardiovascular events	6 months	the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)

Countries

Brazil, Germany

Outcome results

None listed

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