A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis within Bare-Metal Stents

A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis within Bare-Metal Stents - PERVIDEO I Registry

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33458

Enrollment

Registered

2009-07-02

Start date

2009-07-03

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

restenotic lesions - stenosis

Interventions

The intervention is the same as usual performed by patients with in-stent restenosis with exception of the IVUS. IVUS is not part of the standard procedure but is performed on regular basis during a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Target lesions is in a native coronary with previous single bare metal stent Stenosis is >50% and

Exclusion criteria

Exclusion criteria: History of MI or thrombolysis within 72 hours of randomization History of previous target vessel perforation Angiographic evidence of thrombus or dissection within the target vessel

Design outcomes

Primary

Measure	Time frame
Percent (%) Diameter Stenosis (DS) in the Analysis Segment at 6 months	—

Secondary

Measure	Time frame
Clinical (at 1, 6, 12 & 24 months) - Ischemia-driven target vessel revascularization (ID-TVR) defined as targe vessel diameter of at least 50% by Quantitative Coronary Analysis (QCA) with either ECG changes at rest or a positive functional study in the distribution of the target vessel, or stenosis of at least 70% irrespective of symptoms. - Ischemia-driven target lesion revascularization (ID-TLR) - Composite of cardiac death, myocardial infarction, and ID-TLR - Composite of cardiac death, myocardial infarction and target vessel revascularization TVR - Procedural success - Device success	—

Measure

Time frame

Clinical (at 1, 6, 12 & 24 months) - Ischemia-driven target vessel revascularization (ID-TVR) defined as targe vessel diameter of at least 50% by Quantitative Coronary Analysis (QCA) with either ECG changes at rest or a positive functional study in the distribution of the target vessel, or stenosis of at least 70% irrespective of symptoms. - Ischemia-driven target lesion revascularization (ID-TLR) - Composite of cardiac death, myocardial infarction, and ID-TLR - Composite of cardiac death, myocardial infarction and target vessel revascularization TVR - Procedural success - Device success

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)