Assessment of safety and clinical performance of the DREAMS 2nd Generation in de novo coronary artery lesions.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be in-segment late lumen loss (LLL) at 6-month
post-procedure.
Secondary outcome
Clinical
• Target Lesion Failure (TLF; composite of Cardiac Death, Target Vessel Q-wave
or non-Q wave Myocardial Infarction (MI), Coronary Artery Bypass Grafting
(CABG), clinically driven Target Lesion Revascularization (TLR)) at 1, 6, 12,
24, 36 and 60-month
• Scaffold thrombosis rate at 1, 6, 12, 24, 36 and 60-month (according to ARC
definition)
• Procedure success and device Success
Angiographic
• Binary in-scaffold and in-segment restenosis rate at 6, 12 and 36-month
• % in-scaffold and in-segment diameter stenosis at 6, 12 and 36-month
• Late lumen loss in-scaffold at 6, 12 and 36-month and in-segment at 12 and
36-month
OCT and IVUS
• Descriptive analysis of vessel morphology, lesion composition and scaffold
strut data
Vasomotion
• Descriptive analysis of vessel movement
Background summary
Drug-eluting stents (DES) have reduced restenosis rates compared to bare metal
stents (BMS) for the treatement of atheriosclerosis but have been associated
with a risk of late thrombotic events. These complications could be limited by
prolonged dual antiplatelet therapy (DAPT), but are still an issue with an
annual rate of 0.5-0.8%
Bioabsorbable vascular scaffolds (BVS) have been developed to overcome the
limitations of permanent bare metal or drug eluting stents, to reduce the rate
of stent thrombosis, aiming for a reduced duration of DAPT, to avoid creation
of a permanently caged vessel and improved vasomotion and vessel remodeling,
and to avoid chronic vessel wall inflammation. Furthermore a scaffold provide
improved non-invasive vessel lumen imaging by computer tomography or magnetic
resonance technology and facilitate surgical or interventional target vessel
and lesion reintervention.
Currently two different scaffolds technologies are under development, on one
hand scaffolds consisting of absorbable metal like for instance our device
DREAMS consisting of Magensium with the advantage of mechanical performance
comparable to a permanent stent and on the other hand polymeric scaffolds. Up
to now two different polymeric scaffolds are available on the market with
comparable performace to a permanent stent as was seen in clinical studies.
Within the scope of the development of the DREAMS scaffold, earlier versions
have been implanted in about 120 patients to date and its safety was evaluated
in several animal trials. Clinical trials with two earlier versions
demonstrated a good safety profile but the late lumen loss and
revascularization rates were relatively high.
To achieve a comparable performace like a contemporary DES the DREAMS scaffold
was refined incorporating a more flexible, stronger scaffold backbone design
with higher radial force and the exchange of the drug to a more potent
inhibitor of neointima growth. This new version will be evaluated for the first
time in humans within this clinical study.
Study objective
Assessment of safety and clinical performance of the DREAMS 2nd Generation in
de novo coronary artery lesions.
Study design
Up to 121 subjects will be enrolled in this prospective, multi-centre, first in
man trial. Clinical follow-up visits will take place at 1, 6, and 12 months and
annually thereafter until 3 years post procedure and at 5 years post procedure
if subjects consent for the prolongation of follow-up time up to 5 years If a
patient passed away between the 3 year and 5 year follow-up and could not give
the additional informed consent, the date and cause of death should be
captured. These data will not be used in the final analysis, but an overview
should be presented indicating the reason for which patients did not take part
in the prolongation of the study.
All subjects will undergo an angiographic follow-up at 6-month. Additional
imaging methods will be performed IVUS (including additional IVUS-VH analysis)
and OCT for a subset of up to 30 evaluable patients. An additional voluntary
imaging follow-up will be performed at 12-month follow-up and 3 years.
Vasomotion will be assessed angiographically with Acetylcholine followed by
Nitroglycerine, if subject consents.
Intervention
Percutaneous transluminal coronary angioplasty (PTCA) including concomitant
anticoagulation medication according to protocol and implantation of the DREAMS
scaffold. For a subgroup of patients IVUS and OCT for additional imaging after
scaffold implantation will be performed.
Study burden and risks
As with any subject undergoing percutaneous coronary intervention, subjects may
experience adverse events and/or outcomes that may include, but are not
necessarily limited to the following:
Cardiac events:
Myocardial infarction or ischemia, abrupt closure of coronary artery,
restenosis of treated artery (greater than 50% obstruction), cardiogenic shock,
angina, tamponade, perforation or dissection of coronary artery or aorta,
cardiac perforation, emergency cardiac surgery, pericardial effusion, aneurysm
formation, death.
Arrhythmic events:
Ventricular tachycardia, ventricular fibrillation, atrial fibrillation,
bradycardia.
Scaffold system events:
Failure to deliver scaffold to intended site, scaffold dislodgement from the
delivery system, scaffold misplacement, scaffold deformation, scaffold
embolization, scaffold thrombosis or occlusion, scaffold fracture, scaffold
migration, inadequate apposition or compression of scaffold, inflation
difficulties, rupture or pinhole of the delivery system balloon, deflation
difficulties, withdrawal difficulties, embolization of catheter material.
Respiratory events:
Acute pulmonary edema, congestive heart failure, respiratory insufficiency or
failure.
Vascular events:
Access site hematoma, hypotension/hypertension, pseudoaneurysm, arteriovenous
fistula formation, retroperitoneal hematoma, vessel dissection or perforation,
restenosis, thrombosis or occlusion, vasospasm, peripheral ischemia,
dissection, distal embolization (air, tissue debris, thrombus).
Neurologic events:
Permanent (stroke) or reversible (TIA) neurologic event, femoral nerve injury,
peripheral nerve injury.
Bleeding events:
Access site bleeding or hemorrhage, hemorrhage requiring transfusion or other
treatment.
Allergic reactions to contrast media, antiplatelets, anticoagulants, the
scaffold material, PLLA polymer matrix, sirolimus or sirolimus derivatives.
There is a possibility of adverse reactions of the body to the medicinal
component of DREAMS. The exceedingly low quantity of sirolimus in blood plasma
reduces the risk of the known side effects compared to systemic treatment. The
following undesirable effects are known: Abnormal liver values, anaemia, joint
pains, diarrhoea, hypercholesterolaemia, hypersensitivity reaction, including
anaphylactic reaction, hypertriglyceridaemia, hypokalaemia, infections,
interstitial pulmonary disease, lymphoma or other malignant diseases,
thrombocytopenia.
The quantitative coronary angiography performed at 6 and 12 months follow-up
poses some risks or inconveniences. They occur rarely, the most frequent events
are bleedings, infection, and pain at the catheter insertion site, damage to
blood vessels , allergic reaction to contrast media or medication. The use of
X-ray radiation is necessary to carry out the angiogram. Experience with
patients receiving similar treatment has shown that the total additional X-ray
radiation lasts between about 5-10 minutes. This corresponds to a radiation
dose of about 4-6 millisievert (mSv; depending on X-ray system used); as a
comparison: the average exposure to natural radiation per year amounts to about
2.5 mSv.
The additional diagnostic tests IVUS and OCT prolong the angiogram and you may
be exposed to more X-ray radiation and contrast medium. These tests will be
carried out during the coronary angiogram, so that no additional procedure is
necessary.
The vasomotion test involves an infusion of acetylcholine, which can provoke a
pathological narrowing of the vessel, which in turn may lead to chest pain,
reduced blood supply to the heart, cardiac arrhythmia or an occlusion of the
blood vessel. As the vasomotion test is performed during the coronary
angiogram, these side effects are generally easily controlled.
Ackerstrasse 6
Bülach 8180
CH
Ackerstrasse 6
Bülach 8180
CH
Listed location countries
Age
Inclusion criteria
1. Subject is >= 18 years and <= 80 years of age
2. Written subject informed consent available prior to PCI
3. Subjects with stable or unstable angina pectoris or documented silent ischemia
4. Subject eligible for PCI
5. Subject acceptable candidate for coronary artery bypass surgery
6. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
7. Reference vessel diameter between 2.2-3.8 mm by visual estimation, depending on the scaffold size used.
8. Target lesion length <= 21 mm by visual estimation, depending on the scaffold size used.
9. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: >= 50% - < 100%
10. Eligible for Dual Anti Platelet Therapy (DAPT)
Exclusion criteria
1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
2. Evidence of myocardial infarction within 72 hours prior to index procedure
3. Subjects with a >=2 fold CK level or in absence of CK a >=3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
4. Unprotected left main coronary artery disease
5. Three-vessel coronary artery disease at time of procedure
6. Thrombus in target vessel
7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
8. Planned interventional treatment of any non-target vessel within 30 days post-procedure
9. Subjects on dialysis
10. Planned intervention of the target vessel within 6-month after the index procedure
11. Ostial target lesion (within 5.0 mm of vessel origin)
12. Target lesion involves a side branch >2.0 mm in diameter
13. Documented left ventricular ejection fraction (LVEF) <= 30%
14. Heavily calcified lesion
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. The target lesion requires treatment with a device other than the pre-dilatation balloon or cutting/scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
17.Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can*t be covered by a single scaffold), by visual estimation
18. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
19. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
20. Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
21. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
22. Life expectancy less than 1 year
23. Planned surgery or dental surgical procedure within 6 months after index procedure
24. In the investigators opinion subjects will not be able to comply with the follow-up requirements
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 | NCT01960504 |
| CCMO | NL45338.044.13 |