Rapid Exchange Devices Observational Registry.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.

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Detailed Description

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This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology

Conditions

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Peripheral (Lowr Extremity) Arterial Disease.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
* Rutherford classification 2-5
* Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
* Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
* At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
* Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria

* Female of child-bearing potential.
* Previous bypass surgery
* In stent restenosis as a target lesion
* Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
* Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
* Acute thrombophlebitis or deep venous thrombosis
* Hemodynamic instability
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance to study medications, contrast agents or nitinol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No