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

November 20, 2013
July 10, 2014
November 2013
October 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01994798 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Rapid Exchange Devices Observational Registry.
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.

Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
30 Days
Not Provided
Non-Probability Sample

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.

Lower-extremity Peripheral Arterial Disease.
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
525
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Dragica Paunovic, Dr. dragica.paunovic@terumo-europe.com
Belgium,   Spain,   Switzerland
 
NCT01994798
T122E2
Yes
Terumo Europe N.V.
Terumo Europe N.V.
Not Provided
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
Terumo Europe N.V.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP