To demonstrate safety and assess the clinical use and outcomes of the Lutonix® DCB for treatment of stenosis or occlusion of native below-the-knee arteries in a heterogeneous patient population in real world clinical practice.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Freedom from BTK MALE+POD at 30-days
Freedom at 30-Days from the composite of all-cause death, above-ankle
amputation or major reintervention, i.e. new bypass graft, jump/interposition
graft revision, or thrombectomy/thrombolysis, of the index limb involving a
below-the-knee artery.
Efficacy: TLR at 6 months
Defined as clinically-driven target lesion reintervention (TLR).
Secondary outcome
The following will be reported:
* Acute Device and Procedural success
* Primary patency (freedom from total occlusion) at 6, 12 and 24 months
* Freedom from clinically-driven TLR at 12 and 24 months
The following will be reported at 1, 6, 12 and 24 months:
* Above-ankle amputation
* Target vessel reintervention (TVR)
* Unexpected device or drug-related adverse events
* Reintervention for treatment of thrombosis of the target vessel(s)
* Reintervention for embolization to its distal vasculature
* Death (any cause)
The following endpoints will be assessed at 6 and 12 months:
* Wound healing (healed or not; if not, improving, stagnant, worsening)
* New or recurrent lesion (target limb)
* Change in Rutherford Class (target limb)
Background summary
The Sponsor of this registry is Lutonix Inc (hereafter named Lutonix throughout
this protocol), a subsidiary of C. R. Bard, and manufacturer of the Lutonix®
Drug Coated PTA Dilatation Catheter. This post-market registry is intended to
demonstrate safety and assess the clinical use and outcomes of the Lutonix®Drug
Coated PTA Dilatation Catheter in a heterogeneous patient population in real
world clinical practice.
This registry is performed with marketed devices within the indications for
use. There are no
additional treatments or exams that will take place within this registry. The
only differences to
routine care are:
- The collection and analysis of patient data;
- The patient signing an informed consent form;
- The possibility of performing follow-up visits via the telephone, if these
are not routinely performed as on-site visits at the requested times, so that
the data as detailed in Table 1 in Section 5.2 can be obtained; and
- Sponsor personnel or its delegates may witness the procedure.
Study objective
To demonstrate safety and assess the clinical use and outcomes of the Lutonix®
DCB for treatment of stenosis or occlusion of native below-the-knee arteries in
a heterogeneous patient population in real world clinical practice.
Study design
The study will enroll patients presenting with claudication, or critical limb
ischemia (Rutherford Category 3- 5) and an angiographically significant (* 70%)
native artery lesion appropriate for angioplasty that is below the knee.
Subjects will be treated with the Lutonix® DCB carrying the CE Mark per
current IFU and followed clinically for a minimum of 2 years.
Information must be obtained and reported for each subject within each
follow-up window at 1,
6, 12, and 24 months after the index procedure. Contact may be made either by
telephone or by
a clinical visit at 1 and 24 months, and is to be performed as a clinical visit
at 6 and 12 months
post-index procedure.
Study burden and risks
All of the exams and tests are considered standard of care.
The only difference from routine practice at a site is that all adverse events
must be reported and information must be obtained and reported for each subject
within the follow-up window at 1, 6, 12, and 24 months after the index
procedure.
The only additional risks in this registry are related to data collection and
privacy. The procedures in this study are according to standard of care
treatment at sites and independent of the subjects* participation in the study.
No invasive or burdensome study specific
procedures will be performed. Participants' participation in this clinical
study is considered confidential and the records identifying them as subjects
will not made publicly available to the extent required by law. In connection
with their participation in this study, personal information, including
information related to health and information drawn from medical records will
be saved in a study database in a pseudononymous format, analyzed and
forwarded, if required. The data are protected from unauthorized access. Data
will only be decoded under legally prescribed preconditions.
Potential adverse events which may be associated with a peripheral balloon
dilatation
procedure include:
* Additional intervention
* Allergic reaction to drugs or contrast medium
* Aneurysm or pseudoaneurysm
* Arrythmias
* Embolization
* Hematoma
* Hemorrhage, including bleeding at the puncture site
* Hypotension/hypertension
* Inflammation
* Occlusion
* Pain or tenderness
* Pneumothorax or hemothorax
* Sepsis/infection
* Shock
* Stroke
* Thrombosis
* Vessel dissection, perforation, rupture, or spasm
Potential adverse events that may be unique to the Lutonix® Catheter paclitaxel
drug
coating:
* Allergic reaction to drug coating
There may be other potential adverse events that are unforeseen at this time.
Science Center Drive 9409
New Hope MN 55428
US
Science Center Drive 9409
New Hope MN 55428
US
Listed location countries
Age
Inclusion criteria
1. Male or non-pregnant, non-breastfeeding female *18 years of age;
2. Rutherford Clinical Category 3-5;
3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
4. Significant stenosis (*70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
5. Lesion(s) can be treated with available Lutonix® DCB device size matrix per current IFU; and
6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).
NOTE: Outflow must be assessed AFTER pre-dilatation
NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.
Exclusion criteria
Patients will be excluded if ANY of the following conditions apply:
1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02554266 |
| CCMO | NL57581.100.16 |