Rapid Exchange Devices Observational Registry. (RX Registry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Terumo Europe N.V.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01994798
First received: November 20, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition
Lower-extremity Peripheral 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.

Resource links provided by NLM:


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. ] [ Designated as safety issue: Yes ]
  • Total contrast media volume given during the procedure. [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total duration of the procedure [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Total fluoroscopy time [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Total radiation dose given [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Ankle-Brachial Index (ABI) improvement at 30 days. [ Time Frame: 30 Days post procedure ] [ Designated as safety issue: No ]
  • Improvement of the Rutherford index at 30 days. [ Time Frame: 30Days post procedure ] [ Designated as safety issue: No ]
  • Walking distance at 30 days compared with walking distance before procedure. [ Time Frame: 30 Days post procedure ] [ Designated as safety issue: No ]
  • Bleeding complication as per BARC definitions. [ Time Frame: Up to 30 days post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 525
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994798

Contacts
Contact: Dragica Paunovic, Dr. dragica.paunovic@terumo-europe.com

Locations
Belgium
Onze-Lieve-Vrouwziekenhuis (OLV) Aalst Recruiting
Aalst, Belgium
Contact: Roel Beelen, Dr.         
Principal Investigator: Roel Beelen, Dr.         
GasthuisZusters Antwerpen (GZA) Ziekenhuizen Not yet recruiting
Antwerp, Belgium
Contact: Michiel Van Betsbrugge, Dr.         
Principal Investigator: Michiel Van Betsbrugge, Dr.         
Centre Hospitalier Régional (CHR) du Val de Sambre Recruiting
Auvelais-Val de Sambre, Belgium
Contact: Cezar Vazquez, Dr.         
Principal Investigator: Cezar Vazquez, Dr.         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium
Contact: Jean-Pierre Lacquet, Dr.         
Principal Investigator: Jean-Pierre Lacquet, Dr.         
Centre Hospitalier Universitaire (CHU) Liège Recruiting
Liège, Belgium
Contact: Christophe Martinez, Dr.         
Principal Investigator: Christophe Martinez, Dr.         
Spain
Hospital Universitario de Burgos Recruiting
Burgos, Spain
Contact: Medina Maldonado, Dr.         
Principal Investigator: Medina Maldonado, Dr.         
Hospital Universitari Dr. Josep Trueta de Girona Not yet recruiting
Girona, Spain
Contact: Omar Andrés Navarro, Dr.         
Principal Investigator: Omar Andrés Navarro, Dr.         
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Spain
Contact: Bustamante, Dr.         
Principal Investigator: Bustamante, Dr.         
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain
Contact: Vaquero Puerta, Dr.         
Principal Investigator: Vaquero Puerta, Dr.         
Switzerland
Ospedale Regionale di Lugano Not yet recruiting
Lugano, Switzerland
Contact: Josua Van den Berg, Prof.Dr.         
Principal Investigator: Josua Van den Berg, Prof.Dr.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01994798     History of Changes
Other Study ID Numbers: T122E2
Study First Received: November 20, 2013
Last Updated: July 10, 2014
Health Authority: Belgium: Ethics Committee
Switzerland: Ethikkommission
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014