Peripheral (Lowr Extremity) Arterial Disease.RXRegistryNCT01994798
Rapid Exchange Devices Observational Registry.
An observational study of Peripheral (Lowr Extremity) Arterial Disease., run by Terumo Europe N.V. at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral (Lowr Extremity) Arterial Disease.
- How many people
- 525 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Nov 2013to Dec 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Belgium5 sites
Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
Aalst
GasthuisZusters Antwerpen (GZA) Ziekenhuizen
Antwerp
Centre Hospitalier Régional (CHR) du Val de Sambre
Auvelais-Val de Sambre
Jessa Ziekenhuis
Hasselt
Centre Hospitalier Universitaire (CHU) Liège
Liège
Spain4 sites
Hospital Universitario de Burgos
Burgos
Hospital Universitari Dr. Josep Trueta de Girona
Girona
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Clínico Universitario de Valladolid
Valladolid
About this study
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.
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
Measured: From start up to 30 Days post procedure.
Total contrast media volume given during the procedure.
Measured: During procedure
Secondary outcomes (11)
Total duration of the procedure
Measured: During procedure
Total fluoroscopy time
Measured: During procedure
Total radiation dose given
Measured: 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.
Measured: 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.
Measured: During procedure
Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.
Measured: Up to 30 Days post procedure
Total acute device related complication rate defined as any device complication up to 1 month post procedure.
Measured: Up to 30 Days post procedure
Ankle-Brachial Index (ABI) improvement at 30 days.
Measured: 30 Days post procedure
Improvement of the Rutherford index at 30 days.
Measured: 30Days post procedure
Walking distance at 30 days compared with walking distance before procedure.
Measured: 30 Days post procedure
Bleeding complication as per BARC definitions.
Measured: Up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral (Lowr Extremity) Arterial Disease.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 525 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Martinez, Principal investigator, Centre Hospitalier Universitaire (CHU) LiègeOmar Andrés Navarro, Principal investigator, Hospital Universitari Dr. Josep Trueta de GironaJosua Van den Berg, Principal investigator, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994798
- Sponsor's protocol ID
- T122E2
- Acronym
- RXRegistry
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2013
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01994798
- Acronym / sponsor ID
- RXRegistry / T122E2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Martinez principal investigator
Centre Hospitalier Universitaire (CHU) Liège
Omar Andrés Navarro principal investigator
Hospital Universitari Dr. Josep Trueta de Girona
Josua Van den Berg principal investigator
Ospedale Regionale di Lugano
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral (Lowr Extremity) Arterial Disease., run by Terumo Europe N.V. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.