Rapid Exchange Devices Observational Registry. (RXRegistry)

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral (Lowr Extremity) Arterial Disease.

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 Type: Observational
• Enrollment (Anticipated): 525

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
  • Antwerp, Belgium
    • GasthuisZusters Antwerpen (GZA) Ziekenhuizen
  • Auvelais-Val de Sambre, Belgium
    • Centre Hospitalier Régional (CHR) du Val de Sambre
  • Hasselt, Belgium
    • Jessa Ziekenhuis
  • Liège, Belgium
    • Centre Hospitalier Universitaire (CHU) Liège
• Spain
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Girona, Spain
    • Hospital Universitari Dr. Josep Trueta de Girona
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Valladolid, Spain
    • Hospital Clínico Universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with one lesion located in Superficial Femoral Artery(SFA) or popliteal artery planned to be treated as per hospital practice with plain old balloon angioplasty and nitinol stent using monorail (rapid exchange) delivery system.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
Total contrast media volume given during the procedure.	During procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Total duration of the procedure	During procedure
Total fluoroscopy time	During procedure
Total radiation dose given	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.	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
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 acute device related complication rate defined as any device complication up to 1 month post procedure.	Up to 30 Days post procedure
Ankle-Brachial Index (ABI) improvement at 30 days.	30 Days post procedure
Improvement of the Rutherford index at 30 days.	30Days post 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

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.
• Investigators: Principal Investigator: Christophe Martinez, Centre Hospitalier Universitaire (CHU) Liège; Principal Investigator: Omar Andrés Navarro, Hospital Universitari Dr. Josep Trueta de Girona; Principal Investigator: Josua Van den Berg, Ospedale Regionale di Lugano

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: T122E2