To assess the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified, stenotic, de novo coronary lesions prior to stenting.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety
Safety will be assessed by the frequency of major adverse cardiac events (MACE)
within 30 days of the procedure. MACE is defined as:
* Cardiac death
* MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN)
value with or without new pathologic Q wave
* TVR - defined as revascularization at the target vessel (inclusive of the
target lesion) after the completion of the index procedure
Performance
Performance will be assessed by the ability of the Shockwave System to produce
acceptable residual stenosis (* 50%) after stenting with no evidence of
in-hospital MACE.
Each patient that achieves both of these requirements will be considered a
*clinical success*, and the rate of clinical success among patients will be
evaluated.
Secondary outcome
* Quantitative assessment of the residual stenosis in treated lesions
o Angiographic success defined as success in facilitating stent delivery with
<50% residual stenosis and without serious angiographic complications
o Serious angiographic complications defined as severe dissection (Type D to
F), perforation, abrupt closure, and persistent slow flow or persistent no
reflow.
* 180 Day MACE (Post-Market Clinical Follow-up)
The ability of the Shockwave device to achieve a post-Lithoplasty residual
diameter stenosis of *30% (without adjunctive vessel preparation prior to
stenting) as assessed by the operator via visual inspection
Background summary
It concerns a study regarding coronary arteries stenosis.
The standard treatment for the condition is *balloon angioplasty* followed by
placement of a coronary stent (a small mesh tube).
The study device that will be used in this study is called the Shockwave
Coronary Lithoplasty System. It is similar to other balloon devices that are
routinely used during angioplasty procedures; however, it has electrodes inside
the balloon which are designed to deliver energy to crack the calcified
blockage. The Lithoplasty Catheter will be moved over a wire, fed through a
catheter, and placed inside the narrowed part of the vessel. The balloon will
then be inflated to low pressure and pushed against the wall of the artery.
Then the energy source will be activated, delivering sound waves to the vessel
wall. The energy delivered via a generator and the calcium within the vessel
wall responsible for the narrowing within the artery will crack. This allows
the artery to widen with only a small amount of pressure in the balloon. The
energy used in Shockwave Coronary Lithoplasty is the same as what is used to
treat kidney stones. No part of the device will be left behind in your blood
vessel after your angioplasty. A stent will be placed after the lithoplasty to
support the treated area.
Study objective
To assess the safety and performance of the Shockwave Coronary Rx Lithoplasty®
System to treat calcified, stenotic, de novo coronary lesions prior to
stenting.
Study design
Prospective, multi-center, single arm study designed to evaluate the safety and
performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified
lesions in the coronary arteries for the purpose of enhancing the placement of
stents and reducing the ultimate residual stenosis. Patients will be followed
through discharge and at 30 and 180 days.
Intervention
Percutaneous insertion of the Shockwave Coronary Rx Lithoplasty® System for
lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de
novo coronary arteries.
Study burden and risks
The risks relating to balloon angioplasty will have been explained by the
doctor, and those risks exist whether or not the subject takes part in this
study. The risks associated with the study procedure are consistent with any
heart vessel procedure, a minimally invasive procedure to open blocked
arteries, and include the following.
VERY COMMON (* 10%, 10 people in 100)
* Chest pain or discomfort.
COMMON OR FREQUENT (* 1.0% to < 10%, 1 to less than 10 people out of 100)
* Access site pain, hematoma or haemorrhage.
* Vascular complications at access site that might need vessel repair.
* Death.
* Heart attack (myocardial infarction).
* Increased/decreased blood pressure (Hypertension/hypotension).
* Irregular heart rhythm Nausea and vomiting.
* Tearing of the coronary artery (Dissection of the coronary artery).
* Repeat closure of the coronary artery over time (Restenosis of the treated
artery).
UNCOMMON OR INFREQUENT (* 0.1% to < 1.0%, less than 1 person in a 100)
* Allergic reaction to blood-thinning agents (antiplatelet/anticoagulant) or
contrast agent.
* Bleeding complications which may require transfusion.
* Blockage of the coronary artery (total occlusion).
* Contraction causing the coronary artery to narrow slowing or stopping the
blood flow (arterial spasm).
* Decreased blood supply to the limbs (arms and/or legs) possibly causing
cramping, pain (Peripheral ischemia due to vascular injury).
* Dilation of an artery with an actual break in one or more layers of its walls
(Pseudoaneurysm).
* Emergency or non-emergency bypass surgery.
* Fever.
* Fluid development in the lungs (Pulmonary edema).
* Infection/sepsis.
* Movement of air, tissue, or thrombus resulting in blockage in blood flow
(emboli).
* Puncture of the heart artery (arterial perforation) and injury to the
coronary artery.
* Stroke.
RARE (* 0.01% to < 0.1%, less than 1 person in a 1,000)
* Abnormal connection between an artery and a vein next to it (Arterio-venous
fistula).
* Fracture of the guide wire or any component of the device that may or may not
lead to device embolism, serious injury or surgical intervention
* Pericardial effusion (Fluid around the heart).
* Shock.
* Squeezing of the heart due to accumulation of blood in the sac around the
heart (Cardiac tamponade).
* Renal failure/insufficiency.
VERY RARE (< 0.01%, less than 1 person in 10,000)
* Rupture of the heart artery (Arterial rupture).
* Sudden blockage of the artery (Abrupt closure).
In addition, the subject may be exposed to other risks associated with coronary
angioplasty procedures, including risks from conscious sedation and local
anaesthetic, the radiographic contrast agents used during angiography, and the
drugs given to manage the participant during the procedure. These risks are
present in any angioplasty procedure in which the subject would participate
because of his/ her disease. The doctor will explain to the subject the risks
related to balloon angioplasty. These risks exist whether or not the subject
takes part in the study.
There are risks related to the Shockwave Coronary Lithoplasty System. These
risks are uncommon and it is not expected that they will occur. The risks are
listed here below.
* There is a low risk the angioplasty balloon might burst exposing the coronary
artery to the electrode materials. Should this occur the doctor may replace the
device with another device to continue treatment. There are no known problems
related to short term exposure to the probe materials.
* Allergic reaction to the catheter material or coating
* There is a low risk the system may not function properly. Should this occur
the doctor will treat the subject with standard of care.
* There is a low risk that not enough or too many shocks are delivered during
treatment. The doctor can treat the subject with standard of care in the event
that the Shockwave treatment did not help the subject.
* There is a low risk of excess heat at target site due to the system not
functioning properly
* There is a moderate risk that the subject will experience irregular
heartbeats during the procedure. The doctor will monitor the heartbeats
throughout the treatment and it is expected that any irregular heartbeats,
should they occur, will return to normal once treatment is complete.
The type of material used in the trial Coronary Lithoplasty Catheter is also
used in other balloon catheters. The risk of reaction to these materials is
thought to be minimal.
The potential risks of using OCT are similar to balloon angioplasty. Due to the
extended procedure time, (10 minutes) OCT may increase the exposure to
radiation, though the dose would be extremely low. The subject will also
require extra X-ray dye (contrast media) to take the OCT images. In high doses,
the X-ray dye is harmful to the kidneys. However, high doses rarely occur in
these types of procedures, and if so, can be treated effectively with high
fluid (water/saline) volumes that *flush* the X-ray dye out of the kidneys.
Serious complications are rare with OCT.
Pregnant or nursing women are excluded from this study.
At the time of the study, some risks may be unknown.
Benefits
Currently available angioplasty balloons are designed to be blown-up to high
pressures. There are times when the force of the balloon pushing on the blood
vessel wall at this pressure causes damage. The Shockwave balloon is designed
to allow the expansion of vessels at much lower pressure by using sound energy
to break down the calcium in the narrowing. It is believed that the application
of this energy to the blood vessel with this unique balloon will result in less
damage to the blood vessel due to the lower pressure. This could potentially
reduce the risk of some of the common complications seen in angioplasty
procedures with currently available balloons.
It is possible that the subject may have no personal benefit from being in this
study; however, the knowledge gained in this study may be used to help others
in the future with coronary artery disease.
Warm Springs Blvd., Suite # 108 48501
Fremont CA 94539
US
Warm Springs Blvd., Suite # 108 48501
Fremont CA 94539
US
Listed location countries
Age
Inclusion criteria
1. Patient is > 18 years of age
2. Troponin must be less than or equal to the upper limit of lab normal value within 12 hours prior to the procedure
3. The target vessel must have a TIMI flow 3 at baseline
4. Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
6. Single lesion stenosis of protected LMCA, LAD, RCA or LCX artery *50% in a reference vessel of 2.5 mm - 4.0 mm diameter and * 32 mm length
7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
8. Planned treatment of single lesions per vessel
9. Ability to pass a 0.014* guide wire across the lesion
10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
11. Patient is able and willing to comply with all assessments in the study
Exclusion criteria
1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
2. Prior PCI procedure within the last 30 days of the index procedure
3. Patient has planned cardiovascular interventions within 30 days post index procedure
4. Second lesion with >50% stenosis in the same target vessel
5. Left ventricular ejection fraction < 40%
6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
7. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
8. Severe renal failure with serum creatinine >2.5 mg/dL
9. Untreated pre-procedural hemoglobin <10 g/dL
10. Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
11. Patients in cardiogenic shock
12. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated Troponin-I or T (with concomitant elevation of CK) at the time of enrollment
13. History of a stroke or transient ischemic attack (TIA) within 3 months
14. NYHA class III or IV heart failure
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
16. Patients with a life expectancy of less than 1 year
17. Target main branch vessel < 2.4 mm in diameter
18. Target main branch lesion > 32 mm in length
19. Chronic Total Occlusion (CTO)
20. Previous stent procedure within 5 mm of target lesion
21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
22. Unprotected Left Main diameter stenosis * 50%
23. Visible thrombus (by angiography) at target lesion site
24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
25. Patient has active systemic infection
26. Patient has connective tissue disease (e.g., Marfan*s syndrome)
27. Patient has a hypercoagulable disorder
CONFIDENTIAL * Do Not Duplicate without Permission from Shockwave Medical
Shockwave Study Protocol, TD 0257 Revision C Page 11 of 54
28. Uncontrolled insulin dependent diabetes
29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated
30. Evidence of aneurysm in target vessel
31. Patient is pregnant or nursing
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 | NL56014.078.15 |