Atherosclerotic DiseaseNCT02462005
Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.
An observational study of Atherosclerotic Disease, run by Klinikum Arnsberg at 6 sites in 2 countries.
Trial summary
A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon. Interim analysis will be carried out for every 50 subjects enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Disease
- How many people
- 171 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to May 2019
- How long will I take part?
- 24 Months
- 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 from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.
Who may be able to join
- Age ≥ 18 years.
- Patient must be willing to sign a a patient informed consent form.
- Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
- Target vessel reference diameter 2.5 to 8 mm.
Who cannot join
- Subjects pregnant or planning to become pregnant during the course of the study.
- Life expectancy of less than 1 year.
- Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Klinikum Hochsauerland, Karolinen-Hospital
Arnsberg, 59759
Knappschaftskrankenhaus Bottrop
Bottrop, 46242
SRH Klinikum Karlsbad-Langensteinbach GmbH
Karlsbad-Langensteinbach, 76307
Gefaesspraxis im Tal
München, 80331
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292
Switzerland1 site
CHUV, Service de Chirurgie Vasculaire
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.
A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.
Interim analysis will be carried out for every 50 subjects enrolled.
- Conditions
- Atherosclerotic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALL COMERS | Patients implanted or scheduled for an implant with a Ranger Drug coated balloon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.
Measured: 6 Months
Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Measured: 12 Months
Secondary outcomes (10)
Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Measured: 6 and 24 Months
MAE at 12 and 24 months
Measured: 12 and 24 Months
Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)
Measured: Intraoperative
Device success, defined as exact deployment of the device according to the IFU (operator assessment)
Measured: Intraoperative
Procedural success, defined as the combination of technical success and device success
Measured: Intraoperative
Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)
Measured: 6, 12 and 24 months
Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.
Measured: 6, 12 and 24 months
Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.
Measured: 6, 12 and 24 months
Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.
Measured: 6, 12 and 24 months
Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Klinikum Arnsberg
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462005
- Sponsor's protocol ID
- Ranger SFA Registry
- Status last verified
- Jan 2020
- First submitted
- 27 May 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, Saucy F, Rassaf T, Breuckmann F. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). 2018 Feb;59(1):45-50. doi: 10.23736/S0021-9509.17.10261-2. Epub 2017 Oct 3.
PubMed 28980462
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.
- ClinicalTrials.gov ID
- NCT02462005
- Acronym / sponsor ID
- Ranger SFA Registry
- Conditions
- Atherosclerotic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Klinikum ArnsbergUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 3 Jun 2015 (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.
A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.
Interim analysis will be carried out for every 50 subjects enrolled.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL COMERS | – | –Patients implanted or scheduled for an implant with a Ranger Drug coated balloon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Patient must be willing to sign a a patient informed consent form.
- Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
- Target vessel reference diameter 2.5 to 8 mm.
Key exclusion criteria (3 listed)
- Subjects pregnant or planning to become pregnant during the course of the study.
- Life expectancy of less than 1 year.
- Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.
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
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.
Time frame: 6 Months
Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Time frame: 12 Months
10 secondary outcomes
Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Time frame: 6 and 24 Months
MAE at 12 and 24 months
Time frame: 12 and 24 Months
Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)
Time frame: Intraoperative
Device success, defined as exact deployment of the device according to the IFU (operator assessment)
Time frame: Intraoperative
Procedural success, defined as the combination of technical success and device success
Time frame: Intraoperative
Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)
Time frame: 6, 12 and 24 months
Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.
Time frame: 6, 12 and 24 months
Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.
Time frame: 6, 12 and 24 months
Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.
Time frame: 6, 12 and 24 months
Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score
Time frame: 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 28980462Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, Saucy F, Rassaf T, Breuckmann F. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). 2018 Feb;59(1):45-50. doi: 10.23736/S0021-9509.17.10261-2. Epub 2017 Oct 3.
Related trials for Atherosclerotic Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
Not yet recruiting
EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
Atherosclerotic Cardiovascular Disease
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Disease, run by Klinikum Arnsberg at 6 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure. (time frame: 6 Months). 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?
On the ClinicalTrials.gov record for NCT02462005, which also lists 1 linked publication.
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 9 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.