The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions (PCI).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Primary Safety Endpoint:
Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new
myocardial infarction, target vessel revascularization, urgent coronary artery
bypass grafting procedure or cerebral vascular accident during and up to 30
days post-device explant or hospital discharge, whichever is longer.
2. Primary Efficacy Endpoint:
Freedom from Hemodynamic compromise during PCI procedure defined as: Mean
Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes
during the PCI procedure and additional pressor medication is not required.
Secondary outcome
1. Secundary Safety Endpoint:
Other intra-procedural and peri-procedural adverse events (not listed under
primary safety endpoint).
2. Secundary Efficacy Endpoint:
a) Freedom from the following procedural-related events:
i. Ventricular fibrillation
ii. Tachycardia requiring electrical cardioversion
b) Angiographic success defined as residual stenosis <30% after stent
implantation or <50% after balloon angioplasty.
Background summary
Interventional cardiologists are tackling more complex and higher risk cases
during Percutaneous Coronary Interventions (PCI) as device technology and
adjunctive pharmacotherapy improve. However, cardiologists are still exposed to
unusual challenges during high risk PCI because of procedure-related morbidity
and mortality risks related to poor hemodynamic status or reserve. Several
approaches have been developed to provide hemodynamic support during these high
risk PCI cases. However, no single approach has attained a definitive consensus
or received wide acceptance because of either the complexity of the techniques,
their limited effectiveness during hemodynamic collapse, or due to device
related complications.
In an attempt to address some of the limitations of current systems, ABIOMED
developed a miniaturized catheter-based cardiac assist device, the RECOVER LP
2.5, that pumps up to 2.5 l/min of blood from the left ventricle to the
systemic circulation across the aortic valve. First clinical experience showed
that RECOVER LP 2.5 potentially enables immediate and sustained unloading of
the left ventricle while increasing the overall systemic cardiac output.
Study objective
The objective of this feasibility study is to demonstrate that the device is
safe and potentially efficacious for use in patients undergoing high risk
Percutaneous Coronary Interventions (PCI).
Study design
This is a prospective single-arm feasibility study to be conducted at a maximum
of seven institutions. Patients will be considered enrolled in the study
following consent and after the general inclusion/exclusion criteria are met.
Patients will be followed through hospital discharge, at 30 days and three
months postexplant of the IMPELLA RECOVER LP 2.5 System. The study will be
considered complete in regard to the primary study endpoints after all subjects
enrolled have completed their 30 day follow-up or been followed through
discharge, (whichever is longer). Study follow-up will be complete when all
subjects have been followed out to three months.
Intervention
The device under clinical investigation is the IMPELLA® RECOVER® LP 2.5 System.
All patients undergo a high risk PCI under haemodynamic support of the IMPELLA
device.
Study burden and risks
The sponsor believes that the clinical trial is feasible because the potential
benefits outweigh the possible risks. Potential benefits may include
maintenance of hemodynamic stability during the PCI procedure and possible
prevention of procedure-related ventricular fibrillation/tachycardia requiring
electrical cardioversion. The benefits and risks are detailed in section E9 of
this form
and in chapter 5 of the protocol.
22 Cherry Hill Drive
Danvers, MA 01923
Verenigde Staten
22 Cherry Hill Drive
Danvers, MA 01923
Verenigde Staten
Listed location countries
Age
Inclusion criteria
Inclusion criteria
For inclusion in the study, subjects must fulfill all of the following criteria:
1. Signed Informed Consent.
2. Patient is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
3. Age Eligible (40 * Age * 80)
4. Patient has no child bearing potential or has a negative pregnancy test within 7 days prior to treatment.
5. Patient presents with Left Ventricular Ejection Fraction (LVEF) *35%
Subjects must also meet at least one of the following criteria:;a) Intervention on the last patent coronary conduit
b) Intervention on an unprotected left main coronary artery
Exclusion criteria
Exclusion Criteria
1. ST Myocardial Infarction within 7 days
2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR.
3. Subject is in cardiogenic shock defined as:
* CI < 2.2 l/min/m2 and PCWP > 15mmHg
* hypotension (systolic BP < 90 mmHg for > 30 minutes or the
need for supportive measures to maintain a systolic BP of
greater than or equal to 90 mmHg) AND end organ
hypoperfusion (cool extremities OR [a urine output of < 30
ml/hour AND a HR > 60 BPM]).
4. Mural thrombus in the left ventricle.
5. The presence of a mechanical aortic valve or heart constrictive device.
6. Documented presence of aortic stenosis (aortic stenosis graded as
* +2 equivalent to an orifice area of 1.5cm2 or less).
7. Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as * +2).
8. Severe peripheral arterial obstructive disease that would preclude RECOVER LP 2.5 System device placement.
9. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications.
10. Subject with renal dysfunction (creatinine * 3.5mg/dL).
11. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to * 3x ULN or INR (Internationalized Normalized Ratio) * 2.
12. Subject has severe pulmonary disease (FEV1*1, etc.).
13. Subject has uncorrectable abnormal coagulation parameters
(defined as platelet count *75,000/mm3 or INR *2.0 or Fibrinogen * 1.50 g/l.)
14. Subject has sustained or nonsustained ventricular tachycardia.
15. Active systemic infection.
16. History of recent (within 3 months) stroke or TIA.
17. Allergy or intolerance to heparin, aspirin, clopidogrel or contrast media.
18. Patients with documented heparin induced thrombocytopenia.
19. Participation in the active follow-up phase of another clinical study of an investigational drug or device.
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 | NL13284.018.06 |