The primary objective of the study is to assess the safety and performance of Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system (Akesys Prava
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the composite of freedom from perioperative
death (through 30-day follow-up) and freedom from major adverse limb events
defined as the occurrence of major amputation, thrombectomy or thrombolysis, or
major open surgical revascularization through 6-month follow-up
The primary effectiveness endpoint is primary patency defined as freedom from
restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically
driven target lesion revascularization through 6 months.
Secondary outcome
* The composites for the primary safety and effectiveness endpoints will be
tabulated through 12 months as secondary endpoints;
* Technical success; defined at the conclusion of the index procedure as a)
successful delivery and deployment of the study device, b) <30% residual
stenosis, and c) no metallic
* All-cause mortality;
* Major target extremity amputation;
* Minor target extremity amputations;
* Scaffold thrombosis;
* TL binary restenosis by duplex ultrasound (PSVR >2.4;
* Target Lesion Revascularization (TLR) (all);
* Clinically-driven TLR;
* Target extremity revascularization;
* Primary patency of the target lesion (TL);
* Primary-assisted patency of the TL;
* Secondary patency of the TL;
* Rutherford-Becker clinical category;
* Ankle brachial index (ABI) in the target extremity;
* Walking capacity as demonstrated by Walking Impairment Questionnaire (WIQ)
scores;
* Quality of Life Measures using VASCUQOL (disease specific);
* Duplex ultrasound-derived Peak Systolic Velocity (PSV) at the TL;
* Binary restenosis as determined by duplex ultrasound PSVR >2.4.
Background summary
During angioplasty treatment of a blockage or narrowing of the artery in the
upper leg, a balloon is used for dilation of the the blockage or narrowing of
the artery. A stent is placed in order to reduce the risk of the vessel wall,
to re-occlude with narrowing of the artery as result. However, in a substantial
proportion of people who have undergone this treatment, re-occlusion of the
vessels is seen after a while, in some cases leading to a new intervention. In
some patiens, narrowing at the location of the stent occurs. A potential issue
associated with metal stents, with or without drug coatings, is the permanent
nature of the metallic device in the artery. By moving the leg, the metal
stents can break in the thigh artery and also leading to scarring of the blood
vessel and thereby leading to re-stenoses. In addition, the bare metal stent
can limit the possibilities later on should a bypass surgery in the leg be
needed. Therefore, Elixir, as well as other companies have designed
non-permanent scaffolds (stents) that will be completely absorbed by the body
over a period of time, similar to dissolving stitches. With implantation of a
bioresorbable drug-eluting scaffold, the treatment goal is to open the narrow
area in your artery, deliver small amounts of drug locally which will help
prevent re-narrowing in this same area and finally, allow the scaffold itself
will reabsorb over time; essentially leaving nothing behind.
Study objective
The primary objective of the study is to assess the safety and performance of
Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system (Akesys
Prava
Study design
Prospective, multicenter, single-arm study
Intervention
treatment of symptomatic primary atherosclerotic stenoses and occlusions of the
superficial femoral artery (SFA)
Study burden and risks
Patients will be asked to take the standard medication for patients with the
same disease who have undergone endovascular treatment. This may include
aspirin, clopidogrel, prasugrel or ticagrelor. This medication is used to
prevent blood clotting and must be taken for at least 1 year after the
procedure.
The treatment procedure and follow-up visits are similar to standard medical
care, except for the follow-up visit at 6 months, 24 months and 36 months after
the procedure. Not standard two questionnaires that the patients at different
time points have to fill during the study: WIQ (walking impairment
questionnaire) and Quality of Life Questionnaire. time points: pre-procedure,
30 days, 6 months, 12 months, 24 months and 36 months follow-up.
Hermosa Drive 870
Sunnyvale CA 94085
US
Hermosa Drive 870
Sunnyvale CA 94085
US
Listed location countries
Age
Inclusion criteria
Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4)
A single, de novo native disease segment of the SFA
Exclusion criteria
1. Previous bypass surgery or stenting at the target leasion (TL)
2. Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries *30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL;
3. Failure to successfully cross the target lesion with a guide wire;
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 |
|---|---|
| CCMO | NL58385.100.16 |