NCT01994798UnknownNot Applicable
Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.
Terumo Europe N.V.9 sites in 2 countries525 target enrollmentStarted: November 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 525
- Locations
- 9
- Primary Endpoint
- Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Total acute device related complication rate defined as any device complication up to 1 month post procedure.(Up to 30 Days post 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.(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.(During procedure)
- Walking distance at 30 days compared with walking distance before procedure.(30 Days post procedure)
- Bleeding complication as per BARC definitions.(Up to 30 days post procedure)
- Total duration of the procedure(During procedure)
- Total radiation dose given(During procedure)
- Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.(Up to 30 Days post procedure)
- Total fluoroscopy time(During procedure)
- Ankle-Brachial Index (ABI) improvement at 30 days.(30 Days post procedure)
- Improvement of the Rutherford index at 30 days.(30Days post procedure)
Investigators
Study Sites (9)
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