Rapid Exchange Devices Observational Registry. (RXRegistry)
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ClinicalTrials.gov Identifier: NCT01994798 |
Recruitment Status : Unknown
Verified April 2016 by Terumo Europe N.V..
Recruitment status was: Active, not recruiting
First Posted : November 26, 2013
Last Update Posted : April 26, 2016
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Condition or disease |
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Peripheral (Lowr Extremity) Arterial Disease. |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 525 participants |
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. |
Study Start Date : | November 2013 |
Estimated Primary Completion Date : | September 2016 |
Estimated Study Completion Date : | December 2016 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994798
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, Belgium | |
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, Spain |
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 |
Responsible Party: | Terumo Europe N.V. |
ClinicalTrials.gov Identifier: | NCT01994798 |
Other Study ID Numbers: |
T122E2 |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | April 26, 2016 |
Last Verified: | April 2016 |