Peripheral (Lowr Extremity) Arterial Disease. Clinical Trial
— RXRegistryOfficial title:
Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.
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.
| Status | Active, not recruiting |
| Enrollment | 525 |
| Est. completion date | December 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Onze-Lieve-Vrouwziekenhuis (OLV) Aalst | Aalst | |
| Belgium | GasthuisZusters Antwerpen (GZA) Ziekenhuizen | Antwerp | |
| Belgium | Centre Hospitalier Régional (CHR) du Val de Sambre | Auvelais-Val de Sambre | |
| Belgium | Jessa Ziekenhuis | Hasselt | |
| Belgium | Centre Hospitalier Universitaire (CHU) Liège | Liège | |
| Spain | Hospital Universitario de Burgos | Burgos | |
| Spain | Hospital Universitari Dr. Josep Trueta de Girona | Girona | |
| Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
| Spain | Hospital Clínico Universitario de Valladolid | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Terumo Europe N.V. |
Belgium, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC = 3) up to 1 month | From start up to 30 Days post procedure. | Yes | |
| Primary | Total contrast media volume given during the procedure. | During procedure | No | |
| Secondary | Total duration of the procedure | During procedure | No | |
| Secondary | Total fluoroscopy time | During procedure | No | |
| Secondary | Total radiation dose given | During procedure | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure. | Up to 30 Days post procedure | Yes | |
| Secondary | Total acute device related complication rate defined as any device complication up to 1 month post procedure. | Up to 30 Days post procedure | Yes | |
| Secondary | Ankle-Brachial Index (ABI) improvement at 30 days. | 30 Days post procedure | No | |
| Secondary | Improvement of the Rutherford index at 30 days. | 30Days post procedure | No | |
| Secondary | Walking distance at 30 days compared with walking distance before procedure. | 30 Days post procedure | No | |
| Secondary | Bleeding complication as per BARC definitions. | Up to 30 days post procedure | Yes |