Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2017-04-30

Brief Summary

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The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

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Detailed Description

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The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:

* the need for re-dilatation of the previously treated vessel segment
* an ultrasound examination The safety of the IN.PACT Admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

Conditions

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Peripheral Arterial Disease (PAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug-Coated Balloon (DCB)

IN.PACT Admiral: Balloon Angioplasty

Group Type EXPERIMENTAL

Drug-Coated Balloon (DCB)

Intervention Type DEVICE

balloon dilatation and provisional stenting with IN.PACT DCB

Standard PTA

Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty

Group Type ACTIVE_COMPARATOR

PTA Balloon: Balloon Angioplasty

Intervention Type DEVICE

balloon dilatation and provisional stenting with standard non-coated PTA balloon

Interventions

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Drug-Coated Balloon (DCB)

balloon dilatation and provisional stenting with IN.PACT DCB

Intervention Type DEVICE

PTA Balloon: Balloon Angioplasty

balloon dilatation and provisional stenting with standard non-coated PTA balloon

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years and ≤85 years
* Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form

\- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

Exclusion Criteria

* Patient unwilling or unlikely to comply with follow-up schedule
* Stroke or STEMI within 3 months prior enrolment

\- Acute or sub-acute thrombus in the target vessel

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No