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Lower Limb IschemiaPhase 2/3RANGER-BTKNCT02856230

An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

A Phase 2/3 study testing Ranger SL DEB in people with Lower Limb Ischemia and Peripheral Vascular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Ranger SL DEB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
Nov 2016to Nov 2018
Phase
Phase 2/3
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria :
  • Age ≥18 years and ≤85 years
  • Patient signed an approved consent form
  • Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
  • Menopausal or under contraception for women
  • Negative serum β-HCG for women of childbearing age
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  • Angiographic Inclusion Criteria :
  • Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels
  • Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen
  • Reference vessel reference diameter comprised between 2 and 4 mm

Who cannot join

  • General non-inclusion criteria:
  • Patient with known hypersensitivity to paclitaxel
  • Patient unwilling or unlikely to comply with Follow-Up schedule
  • Life expectancy <1 year (investigator's appreciation)
  • Planned major index limb amputation
  • Pregnant or breast feeding women
Show all 12Show fewer
  • Angiographic exclusion criteria:
  • Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral or popliteal artery that cannot be treated successfully in the same session
  • Previously implanted stent in the target lesions(s)
  • Aneurysm in the target vessel
  • Acute thrombus in the target limb
  • Failure to cross the target lesion

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP - Hopital Europeen Georges-Pompidou Paris, France

    Paris, Île-de-France Region, 75908

Other trials in France

About this study

Official title: An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia

Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients.

Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results.

The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.

Being tested
Ranger SL DEB
Keywords
Critical limb ischemia, bellow-the-knee angioplasty, drug-eluting balloon
Medical subject headings
Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranger SL DEBDevice

    Also called Ranger SL paclitaxel-eluting balloon

    BTK angioplasty using Ranger SL DEB

Study groups in NCT02856230
Study groupRoleWhat they receive
Ranger SL DEB angioplastyExperimentalpatients filling general and angiographic inclusion/exclusion criteria will have an BTK angioplasty using one or several Ranger SL drug-eluting balloons
Receives: Device: Ranger SL DEB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Number of deaths and major amputations

    Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure

    Measured: 6 months

  2. Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

    Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

    Measured: 6 months

Secondary outcomes (13)

  1. Composite of all death and major amputation

    Number of deaths and major amputations (any amputation above the knee) at 12 months after procedure

    Measured: 12 months

  2. Number of SAEs

    Procedure related or contributed total number of SAEs

    Measured: 12 months

  3. Number of AEs

    Procedure related or contributed total number of AEs

    Measured: 12 months

  4. Late Lumen Loss (LLL)

    Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

    Measured: 6 months

  5. Clinically driven Target Lesion Revascularization (TLR)

    Clinically driven TLR is defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and/or increase in size of pre-existing wounds and / or occurrence of a new wound(s)

    Measured: 6 and 12 months

  6. Amputation Free Survival

    Measured: 6 and 12 months

  7. Rate of Wound Healing

    Measured: 6 and 12 months

  8. Quality of Life

    Quality of Life assessed by EQ5D questionnaires

    Measured: 6 and 12 months

  9. Ulcer diameter

    Ulcer diameter in the target limb

    Measured: 1, 6 and 12 months

  10. ABI (Ankle-Brachial Index)

    ABI in the target limb

    Measured: 1, 6 and 12 months

  11. Toe pressure

    Toe pressure in the target limb

    Measured: 1, 6 and 12 months

  12. Device success rates

    Percentage of exact deployment of the device according to the instructions for use as documented with suitable imaging modalities

    Measured: Through angioplasty completion

  13. Technical success rates

    Percentage of successful vascular access, completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography

    Measured: Through angioplasty completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856230
Sponsor's protocol ID
P151101
Other IDs
IDRCB 2016-A00035-46
Acronym
RANGER-BTK
Status last verified
May 2018
First submitted
19 Jul 2016
Last updated
18 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ranger SL DEB in people with Lower Limb Ischemia and Peripheral Vascular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 10 inclusion and 12 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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: Number of deaths and major amputations (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 NCT02856230.

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 18 May 2018.

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