A Study of the Experimental XIENCE Device System for Patients Who Need Coronary Stenting (device to keep a heart artery open)
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"The study will research the safety of aspirin plus 3 months of a second blood thinner in coronary stenting procedures."
Age: 18+ years old
Gender:
Any
Healthy Volunteers: No
Keywords: coronary artery disease, coronary stent
Type: Device study
Target:
10 Participants
Investigator:
Description
Coronary artery disease is a narrowing of one or more blood vessels (coronary arteries) that supply blood and oxygen to the heart.

Coronary stenting is a commonly used procedure to treat coronary artery disease. Some stents, called drug-eluting stents, are coated with a drug. This improves the performance of the stent by reducing the risk of artery re-narrowing. Your doctor will determinte if you are a good candidate for a type of drug-eluting stent called the XIENCE stent.

The XIENCE stent systems are all made of a metal mesh tube which contains a drug. An expandable balloon delivers the stent to the narrowed area of the heart’s artery. Once the stent is placed, it remains permanently within your artery. The drug coating on the XIENCE stent is called everolimus. The everolimus coating on the stent helps prevent your coronary artery from re-narrowing. The majority of the drug is released into the vessel within 30 days.

To help prevent blood clots that could block the opening of your stent and lead to a heart attack, your doctor will require you to take aspirin. You will also receive another blood thinner or anti platelet medication, determined by the study doctor.

Antiplatelet therapy, or blood thinners, can reduce the risk of heart attack, stroke, and even death. They help prevent blood clots within the stent (stent thrombosis). Following placement of a stent, your body immediately begins the healing process. Your body’s healing reaction to the stent in your coronary artery is similar to your body’s reaction to a cut on your finger. Platelets in your bloodstream clump at the affected site and have the potential to form blood clots. Aspirin and other antiplatelet medications work differently. This is why a combination of antiplatelet medications provides the best defense against blood clots.

The study will research the safety of aspirin plus 3 months of a second blood thinner (antiplatelet) medication [clopidogrel (Plavix), or prasugrel (Effient), or ticagrelor (Brilinta)] in people who have a XIENCE stent. The length of time that you may be prescribed by your doctor to take one of these medications (3 months) is investigational.
This study requires

In order to meet requirements for participation in this study, you must receive at least one XIENCE stent. Your study doctor will confirm you qualify for this study. Information on your medical history and any blood thinning (antiplatelet) medications will also be collected.

Angiogram/Coronary Stenting Procedure

BEFORE PROCEDURE: Potential Study subjects may receive the following standard of care tests and procedures:

  • Short interview.
  • Physical examination.
  • Blood test.
  • Electrocardiogram (ECG).
  • Pregnancy test.

DURING PROCEDURE: Your Study Doctor will perform an angiogram (special x-ray of your coronary artery). It will be done at the beginning of your procedure to determine where the narrowing is and how much narrowing you have.

The stent procedure is routine. Your Study Doctor will tell you what he or she will do before, during and after placement of your stent.

First, your Study Doctor may use a special x-ray (angiogram) to move a long, thin, hollow tube (catheter) with a deflated balloon mounted on its tip through your heart artery and into the narrowed area (lesion). Your Study Doctor will temporarily inflate the balloon to push open the narrowed part of the artery, pushing the blockage against the artery wall. This stretches the narrowed artery open so blood can flow more easily to the heart. Then the balloon is deflated and taken out of the artery. Second, your Study Doctor will implant a XIENCE stent into your heart artery. The device is placed over a balloon catheter and delivered to the narrowed part of the heart artery. When the balloon is inflated, the device expands and is pressed against the wall of the heart artery. Once the stent is properly placed, the balloon will be removed from your body. The delivery catheter is then removed, leaving the stent in your artery. Finally, your Study Doctor may move another catheter with a deflated balloon through the stented area of your heart artery and temporarily inflate the balloon to expand the stent further. This balloon will then be deflated and taken out of the artery. The first and last steps of balloon inflation prior to and after stent implant are optional for this kind of stent procedure and will be decided by your Study Doctor.

AFTER PROCEDURE: Before you are released from the hospital, you may receive the following standard of care tests:

  • Blood Test.
  • Electrocardiogram (ECG).

After hospital discharge you will be asked to return up to 3 times for follow-up visits. The first follow-up will take place at approximately 90 days (3 months). The other two visits can be conducted via in office visit or telephone at 180 days (6 months), and 365 days (1 year).

Who can participate

Inclusion criteria:

  1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration:
  2. ≥ 75 years of age.
  3. Clinical indication for chronic or lifelong anticoagulation therapy.
  4. History of major bleeding which required medical attention within 12 months of the index procedure.
  5. History of stroke (ischemic or hemorrhagic).
  6. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
  7. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm^3, or any known coagulation disorder associated with increased bleeding risk).
  8. Anemia with hemoglobin < 11g/dl.
  9. Subject must be at least 18 years of age.
  10. Subject or a legally authorized representative must provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
  11. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, if eligible per protocol.
  12. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. Angiographic Inclusion Criteria
  13. Up to three target lesions with a maximum of two target lesions per epicardial vessel.
  14. Target lesion ≤ 32 mm in length by visual estimation.
  15. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  16. Exclusive use of XIENCE family of stent systems during the index procedure.
  17. Target lesion has been treated successfully, which is defined as achievement of a final instent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation or depression lasting > 5 minutes.

Exclusion criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI) or non ST-segment elevation MI (NSTEMI), defined as acute ischemic symptoms occurring within 72 hours before index procedure and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis (CK-MB [creatine kinase myocardial-band isoenzyme] or troponin T or I greater than the upper limit of normal; If CK-MB or troponin is not available, total CK (creatine kinase) > 2 times upper limit of normal).
  2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  3. Subjects who had additional clinically significant lesion(s) in target or non-target vessel for which PCI may be required within 12 months after the index procedure.
  4. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  5. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  6. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
  7. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure.
  8. Subject with a current medical condition with a life expectancy of less than 12 months
  9. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
  10. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  11. Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
  12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Angiographic Exclusion Criteria
  13. Target lesion is in a left main location.
  14. Target lesion is located within an arterial or saphenous vein graft.
  15. Target lesion is restenotic from a previous stent implantation.
  16. Target lesion is a total occluded lesion (TIMI flow 0).
  17. Target lesion contains thrombus as indicated in the angiographic images.
  18. Target lesion is implanted with overlapping stents, whether planned or for bailout.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefit to you from participating in this research study.

RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be compensated for your participation.
Resources
Schedule
Study duration and period
You will be in the study for approximately 12 months after your stenting procedure.
Recruitment period
From Nov. 13, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Coronary Artery Lesions