To evaluate the safety and effectiveness of the SINOMED BuMA Supreme Sirolimus-Eluting Coronary Stent System with biodegradable polymer versus the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System through angiographic and clinical…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed
by off-line QCA.
Secondary outcome
Angiographic endpoints:
* Acute Lumen Gain (mm);
* In-segment LLL (mm) at 9 months;
* MLD (mm) post procedure and at 9 months;
* Diameter Stenosis (%) post procedure and at 9 months;
* Binary Restenosis (DS *50%) at 9 months.
All measurements will be made of the in-stent, in-segment, proximal and distal
stent margins.
Clinical endpoints:
* Acute success (device and procedural success);
* Device-oriented Composite Endpoints (DoCE) at 1, 9, 12, 24 and 36 months and
its individual components. (Device-oriented Composite Endpoint is defined as
Cardiac Death, MI not clearly attributable to a non-intervention vessel, and
clinically-indicated Target Lesion Revascularization);
* Death at all time points;
* Myocardial infarction (Q-wave, Non q-wave) at all time points;
* Revascularization of the target vessel, clinically indicated at all time
points;
* Any revascularization at all time points;
* Stent thrombosis according to the ARC definitions up to 36 months follow-up.
Background summary
One of the patient's coronary arteries has a significant narrowing that is
causing decreased blood flow to the heart muscle. To prevent damage to the
heart muscle, this narrowing has to be resolved. This is commonly done with a
percutaneous coronary intervention (PCI). The procedure is performed by
entering the arteries with a catheter through the groin or arm. By X-ray, the
coronary arteries are made visible. A balloon and then a stent are placed
within the narrowing in the artery to achieve the desired result; a reopened
artery with good blood flow.
Stent placement means that a small metal scaffold (stent) is left behind after
the balloon is removed and the stent becomes a permanent part of the artery.
Stents have been used for many years to treat narrowing of both coronary
arteries. There are simple metal stents and drug eluting stents (DES). In this
trial drug eluting stents are used, which gives a reduction of restenosis or
re-narrowing of the artery. The procedure itself is a standard procedure for
this condition.
Study objective
To evaluate the safety and effectiveness of the SINOMED BuMA Supreme
Sirolimus-Eluting Coronary Stent System with biodegradable polymer versus the
Medtronic Resolute Zotarolimus-Eluting Coronary Stent System through
angiographic and clinical endpoints.
Study design
Prospective, multi-center, randomized 1:1, single blind trial using BuMA
Supreme versus Resolute conducted in approximately 12-14 interventional
cardiology centers in The Netherlands, Belgium, Spain and Portugal.
Clinical follow-up will occur at 1, 9, 12, 24 and 36 months post-stent
implantation. All patients will undergo repeat angiography at 9 months
follow-up. QCA assessment will be performed at baseline (pre- and
post-procedure) and at 9 months follow-up.
Intervention
BuMA Surpreme stent or Resolute stent
Study burden and risks
Burden:
The patient needs to visit the hospital a few times for additional visits which
will take extra time.
Risks:
The amount of Zotarolimus released by the Resolute stent and the amount of
Sirolimus released by the BuMA Surpreme stent is a very small percentage of the
dose given orally for months or even years for treatment of other diseases.
This treatment may involve some additional risks to the patient, the nature of
which are unknown. Potential risk in case of pregnancy are not known for this
treatment, therefore the use of adequate birth control during the course of the
trial is mandatory for women in their fertile period.
Potential complications and adverse effects due to the use of this stent are
the same to any routinely performed coronary stenting procedure and therapy.
These can be: death, stroke, heart attack, renarrowing of the coronary artery
or another coronary artery, necessity of bypass surgery or rePCI.
Benefits:
A potental benefit is that animal studies suggest that the BuMA stent could be
associated with a better early endothelialization due to an ultra thin base
layer. The PIONEER trial is designed to assess the safety and efficacy of the
BuMA Supreme stent in comparison with the Resolute zotarolimus eluting stent.
Participation of the trial might not have a direct benefit, but it will
contribute to the valuable knowledge of researchers and physicians for
treatment of future patients with the same condition. The medical condition of
the patient is closely monitored during the trial.
2nd floor, TEDA Biopharm Research, Building B, #5 4th St TEDA 5
Tianjin 300457
CN
2nd floor, TEDA Biopharm Research, Building B, #5 4th St TEDA 5
Tianjin 300457
CN
Listed location countries
Age
Inclusion criteria
1. At least 18 years of age.
2. Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
3. Clinical evidence of myocardial ischemia and/or a positive territorial functional study. Stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or silent ischemia
4. The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
5. Diameter Stenosis *50 and *100%.
6. The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute stent (for available sizes refer to table x, page x).
7. The target lesion reference diameter must be visually estimated to be *2.5 mm and *4.5 mm in diameter.
8. Written informed consent.
9. The patient agrees to the follow-up visits including a 9 month angiographic follow-up.
10. Patient must have completed the follow-up phase of any previous study.
Exclusion criteria
1. Female of child bearing potential (age <50 years and last menstruation within the last 12 months). Subjects with age <50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.
2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
3. Patient suffered from stroke/TIA during the last 6 months.
4. LVEF <30%
5. Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
6. Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance *30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).
7. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.
8. Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))
9. History of bleeding diathesis or coagulopathy
10. The patient is a recipient of a heart transplant
11. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.
12. Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
13. The patient is simultaneously participating in another investigational device or drug study.
Angiographic Exclusion criteria
The following angiographic exclusion criteria are applied:
1. Target lesion in left main stem.
2. Target lesion involves a side branch >2.0mm in diameter
3. Aorto-ostial target lesion (within 3 mm of the aorta junction).
4. Total occlusion or TIMI flow <2, prior to wire crossing
5. The target vessel contains visible thrombus
6. Restenotic lesion.
7. The lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
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 | NCT02236975 |
| CCMO | NL50420.044.14 |