The study objective is to assess the safety and efficacy of the Svelte DES-IDS and the Svelte DES-RX compared to a commercially available Xience or Promus Drug-Eluting Stent in subjects with up to three de novo coronary artery lesions in up to two…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Non-inferiority of Target Lesion Failure (TLF) at 12 months post-procedure
defined as: Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave
and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by
percutaneous or surgical methods
Secondary outcome
• TLF at 6 months post-procedure and annually from 2-year through 5-year
follow-up.
• TVF at 6 and 12 months post-procedure, and annually through 5-year follow-up
defined as cardiac death, TVMI, or clinically-driven TVR by percutaneous or
surgical methods.
• TLR and TVR total and clinically-driven at 6 and 12 months post-procedure and
annually through 5-year follow up.
• MACE at 6 and 12 months post-procedure and annually through 5-years
follow-up, defined as all-cause mortality, TVMI and clinically- driven TLR.
• Total Death (cardiac and non-cardiac) at 6 and 12 months post-procedure and
annually through 5-year follow up.
• TVMI at 6 and 12 months post-procedure and annually through 5-year follow up.
• ST at 30 days, 6 and 12 months post-procedure, and annually through 5-year
follow up using the ARC definitions.
• Acute success rates:
• Device Success: Attainment of < 30% final residual stenosis of the target
lesion using only the randomized stent;
• Lesion Success: Attainment of < 30% final residual stenosis of the target
lesion using any stent with or without other interventional devices;
• Procedure Success: Lesion success and no in-hospital Major Adverse Cardiac
Event (MACE).
• Direct Stent Strategy Success: Attainment of < 30% final residual stenosis of
the target lesion without pre-dilatation if the operator had originally chosen
to proceed using a direct stent approach;
• Procedure time: Begins with placement of the introducer sheath and ends with
removal of all interventional and diagnostic devices
• Intervention time: Begins with the time the guiding catheter is inserted into
the subject until it is removed
• Device time: Begins with the time the guide wire tip exits the guiding
catheter until the time the guide wire tip is fully retrieved back into the
guiding;
• Puncture site complications, need for transfusion, hematoma formation
• For each subject, contrast volume (mL) and exposure to fluoroscopy (time and
grays) is to be recorded at the beginning of the PCI (i.e., at the time of
guiding catheter insertion). In the case of ad-hoc PCI, if contrast volume and
exposure to fluoroscopy cannot be recorded beginning only with PCI, then these
data points
are to be collected for the entirety of the diagnostic and interventional
procedure.
Background summary
Different studies comparing 'direct stenting' with conventional stenting (with
predilation) demonstrate a high degree of technical and procedural success with
direct stenting, including a significant reduction in the procedure time,
radiation exposure, contrast use and cost. Direct stenting (such as with the
Svelte system) offers the possibility of reducing risk factors, which is
especially important in high risk patients (elderly, multiple blood vessels,
chronic renal disease and peripheral arterial disease).
This study has been designed to gather further information on the safety and
the performance of the Svelte Integrated Delivery System for the treatment of
de novo stenotic lesions in native coronary arteries.
Although studies have shown that the use of drug-eluting stents (especially
sirolimus eluting) provide better outcomes than bare metal stents, there are
concerns about the biocompatibility of the polymers which carry the drug. As
these polymers can cause inflammation, leading to restenosis and possibly
thrombosis, there is great interest in developing bioerodible,non-inflammatory
polymers (as used with the Svelte system).
Study objective
The study objective is to assess the safety and efficacy of the Svelte DES-IDS
and the Svelte DES-RX compared to a commercially available Xience or Promus
Drug-Eluting Stent in subjects with up to three de novo coronary artery lesions
in up to two native coronary artery vessels.
Study design
A prospective, single-blind, randomized, active-control, multi-center clinical
trial comparing the safety and efficacy of the Svelte Sirolimus-Eluting
Coronary Stent Integrated Delivery System (Svelte DES-IDS) and Svelte
Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System (Svelte DES-RX)
to that of the commercially available Abbott Vascular Xience or Boston
Scientific Promus Drug-Eluting Coronary Stents. In this study, subjects will
have stents placed for primary treatment of symptomatic ischemic heart disease.
One thousand six hundred and thirty (1630) subjects (1:1 randomization Svelte
DES-IDS or DES-RX to Xience or Promus DES) will be treated in up to one hundred
twenty (120) sites in the United States, Europe and Japan to establish
non-inferiority in the primary endpoint of Target Lesion Failure (TLF).
Follow-up contacts post procedure will be made for clinical assessments at
30-days, 6 months, 12 months and annually through 5 years.
Intervention
Angiography and coronary angioplasty
Study burden and risks
Svelte has conducted risk analysis for the Svelte Sirolimus-Eluting Coronary
Stent Integrated Delivery System (DES-IDS) and Svelte Sirolimus-Eluting
Coronary Stent Rapid Exchange System (DES-RX) and concluded that from a
technology, construction, material, application and design perspective
intolerable risks were either not inherent to the design of the device or were
successfully mitigated. The Svelte DES obtained CE Mark and is commercially
available in select accounts in Europe, utilizing either a radial and femoral
approach.
Potential or Anticipated Adverse Events Adverse events may be associated with
the use of any coronary stent in native coronary arteries:
• Access site pain, hematoma, hemorrhage or infection
• Allergic reaction to contrast, antiplatelet therapy, CoCr, PEA or sirolimus
• Aneurysm, pseudoaneurysm or arteriovenous fistula (AVF)
• Arrhythmias
• Cardiac tamponade
• Coronary artery spasm, abrupt closure, occlusion, perforation or dissection
• Coronary stent dislodgement or embolism
• Coronary stent thrombosis
• Death
• Embolism - air, tissue or thrombus
• Emergent or non-emergent peripheral vascular or coronary artery bypass graft
surgery
• Fever or infection
• Hypotension / hypertension
Intervention due to:
• Failure to deliver stent
• Stent deformation, collapse or fracture
• Stent migration or embolization
• Myocardial ischemia or infarction
• Peripheral ischemia / peripheral nerve injury, renal insufficiency or failure
• Restenosis of stented artery
• Stroke / TIA
• Thrombosis - stent or other
• Unstable or stable angina The following additional side effects/complications
may be associated with, but not limited to, the use of sirolimus and poly(ester
amides):
• Anemia
• Diarrhea
• Dry mouth and/or dry skin
• Headache
• Pain - abdominal or arthralgia
• Rash
675 Central Avenue, Suite 2
New Providence, New Jersey 07974
US
675 Central Avenue, Suite 2
New Providence, New Jersey 07974
US
Listed location countries
Age
Inclusion criteria
1. Subject is >= 18 years old;
2. Subject (or subject*s legal representative) understands the
study requirements, the treatment procedures and provides
written informed consent before any study-specific tests or
procedures are performed;
3. Japan only: for subjects < 20 years of age, the subject and the
subject*s legal representative must provide written informed
consent before any study specific tests or procedures are
performed;
4. Subject is an eligible candidate for PCI;
5. Subject has symptomatic coronary artery disease with objective
evidence of ischemia or silent ischemia;
6. Subject has clinical symptoms or ECG changes consistent with
non-ST elevation MI (NSTEMI), is clinically and
hemodynamically stable and has cardiac enzymes documented
to be decreasing prior to the study procedure (CK-MB is
preferred, but if troponin is assessed, enzymes decreasing,
stable or elevated up to 20% over the prior assessment are
acceptable);
7. Subject is an acceptable candidate for CABG;
8. Subject agrees to comply with specified follow-up evaluations.;Angiographic Inclusion Criteria (visual estimate):
1. Subject has <= 3 de novo target lesions in <= 2 native coronary
artery vessels, with <= 2 lesions in a single vessel, each meeting
the angiographic criteria and none of the exclusion criteria.
2. Target lesion(s) must be located in a native coronary artery
with RVD >= 2.25 mm and <= 4.00 mm;
3. Target lesion(s) length must be <= 34 mm in length (the intention
should be to cover the whole lesion with one (1) stent of
adequate length);
4. Target lesion(s) must have visually estimated stenosis >= 50%
and < 100% with Thrombolysis in Myocardial Infarction (TIMI)
flow > 1. For lesions with visually estimated stenosis >= 50%
and <= 70%, additional confirmation by ACC/AHA guideline
compliant physiologic assessment is required;
5. Coronary anatomy is likely to allow delivery of a study device(s)
to the target lesion(s).
Exclusion criteria
1. Subject has clinical symptoms or ECG changes consistent with acute STEMI; Subject may be included if primary PCI for STEMI was successfully completed and subject is clinically and hemodynamically stable with cardiac enzymes documented to be decreasing >= 72 hours prior to the study procedure;
2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina;
3.- Subject has received an organ transplant or is on a waiting list for an organ transplant;
4. Subject is receiving or scheduled to receive chemotherapy 30 days before or after the index procedure;
5. Subject requires a planned PCI (including staged procedures) or CABG after the index procedure; CABG or surgical or catheter-based valvular intervention within 12 months of) the index procedure;
6. Subject was previously treated at any time with intravascular brachytherapy;
7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the study stent systems or protocol-required concomitant medications (e.g. platinum, platinum-chromium alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin);
• Subject has one of the following (as assessed prior to the index procedure):
a. Other serious medical illness (e.g. cancer, congestive heart failure) with estimated life expectancy of <=24 months;
b. Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.);
c. Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
9. Subject is receiving chronic (>=72 hours) anticoagulation therapy (e.g. heparin, coumadin) for indications other than acute coronary syndrome (ACS);
10. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3;
12. Subject has documented significant liver disease including laboratory evidence of hepatitis;
13. Subject is on dialysis or has a baseline serum creatinine level > 2.0 mg/dL (177µmol/L);
14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
15. Subject has a history of a CVA or a TIA within the past 6 months;
16. Subject has an active peptic ulcer or active GI bleeding;
17. Subject has severe symptomatic heart failure (i.e. NYHA class IV);
18. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
19. Subject has a known intention to procreate within 12 months after the index procedure (a woman of child bearing potential who is sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure);
20. Subject is pregnant or nursing (subject must have a negative pregnancy test within 14 days prior to the index procedure if a woman of childbearing potential);
21. Subject is participating in another investigational drug or device study;
22. Planned use of cutting balloon, atherectomy or atherectomy orbital, laser or other) any other form of treatment of the target lesion(s) during the index procedure other than plain balloon angioplasty and the randomized stent.;Angiographic Exclusion Criteria (visual estimate):
1. Subject has a planned treatment of >= 3 lesions;
2. Subject has a planned treatment of >= 2 major epicardial vessels;
3. Subject has a planned treatment of a single lesion with >= 1 stent;
4. Subject has 2 target lesions in the same vessel that are separated by <= 15 mm ;
5. Subject*s target lesion(s) is located in the left main coronary artery;
6. The subject*s target lesion(s) is located within 3 mm of the origin of the (LAD or LCX) coronary arteries ;
7. Subject*s target lesion(s) is located within a saphenous vein graft (SVG) or arterial graft;
8. Subject*s target lesion(s) will be accessed via SVG or arterial graft;
9. Subject has a target lesion(s) with TIMI flow of 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing;
10. Subject*s target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g. bifurcation lesion requiring treatment with more than one (1) stent); see Complex Bifurcation definition in the Definition section of this protocol.)
11. Subject*s target lesion is located within 10 mm of a previously implanted stent or involves in-stent restenosis.
12. Subject has unprotected left main coronary artery disease (> 50% diameter stenosis);
13. Subject has been treated with any type of PCI (i.e. balloon angioplasty, stent, cutting balloon or atherectomy) within 24 hours of the index procedure
14. Subject has thrombus or possible thrombus, present in the target vessel (by visual estimate).
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 | NCT03190473 |
| CCMO | NL62683.100.17 |