Overview

This trial is active, not recruiting.

Condition peripheral (lowr extremity) arterial disease.
Sponsor Terumo Europe N.V.
Start date November 2013
End date September 2016
Trial size 525 participants
Trial identifier NCT01994798, T122E2

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
time frame: From start up to 30 Days post procedure.
Total contrast media volume given during the procedure.
time frame: During procedure

Secondary Outcomes

Measure
Total duration of the procedure
time frame: During procedure
Total fluoroscopy time
time frame: During procedure
Total radiation dose given
time frame: During procedure
Technical success defined as a successful access and balloon angioplasty followed by stent placement with achieved recanalization determined by less than 30% residual stenosis by angiography at the baseline procedure.
time frame: Pre- and post-procedure
Clinical success defined as technically successful procedure without the events considered in safety composite endpoint (all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month.
time frame: During procedure
Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.
time frame: Up to 30 Days post procedure
Total acute device related complication rate defined as any device complication up to 1 month post procedure.
time frame: Up to 30 Days post procedure
Ankle-Brachial Index (ABI) improvement at 30 days.
time frame: 30 Days post procedure
Improvement of the Rutherford index at 30 days.
time frame: 30Days post procedure
Walking distance at 30 days compared with walking distance before procedure.
time frame: 30 Days post procedure
Bleeding complication as per BARC definitions.
time frame: Up to 30 days post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.
Principal investigator Christophe Martinez
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Terumo Europe N.V..