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Rapid Exchange Devices Observational Registry. (RXRegistry)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Terumo Europe N.V. Identifier:
First received: November 20, 2013
Last updated: April 22, 2016
Last verified: April 2016
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.

Peripheral (Lowr Extremity) Arterial Disease.

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
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.

Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 525
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01994798

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, Belgium
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, Spain
Sponsors and Collaborators
Terumo Europe N.V.
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
  More Information

Responsible Party: Terumo Europe N.V. Identifier: NCT01994798     History of Changes
Other Study ID Numbers: T122E2
Study First Received: November 20, 2013
Last Updated: April 22, 2016 processed this record on May 25, 2017