Clinical trial NCT02236975: First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
Official title: Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.

Clinical follow-up will occur at 1, 9 and 12 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.


Eligibility criteria: Inclusion Criteria:

1. The subject is at least 18 years of age.
2. Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
3. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented 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 Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).
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

Primary outcomes:
measure: Late Lumen Loss
timeFrame: Up to 9 month
Secondary outcomes:
measure: Angiographic endpoint
timeFrame: 9 and 12 month
measure: Angiographic endpoint
timeFrame: 9 and 12 month
measure: Angiographic endpoint
timeFrame: 9 and 12 month
measure: Angiographic endpoint
timeFrame: 9 and 12 month
measure: Clinical endpoint
timeFrame: 9 and 12 month
measure: Cinical endpoint
timeFrame: 9 and 12 month
measure: Clinical endpoint
timeFrame: 9 and 12 month
measure: Clinical endpoint
timeFrame: 9 and 12 month
measure: Clinical endpoint
timeFrame: 9 and 12 month
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Chaleroi
country: Belgium
facility: CHU Chaleroi
city: Genk
country: Belgium
facility: Oost-limburg Hospital
city: Amsterdam
country: Netherlands
facility: AMC
city: Amsterdam
country: Netherlands
facility: OLVG
city: Groningen
country: Netherlands
facility: UMCG
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Almada
country: Portugal
facility: Hospita; Garcia de Orta
city: Lisboa
country: Portugal
facility: Santa Maria University Hospital
city: Oporto
country: Portugal
facility: Gaia/Espinho Hospital Centers
city: Madrid
country: Spain
facility: University Hospital Madrid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Medisch Spectrum Twente (MST), Enschede, the Netherlands
name: Clemens von.Birgelen, MD,Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic university hospital Barcelona, Spain
name: Manel Sabate, MD,Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam
name: Patrick W.Serruys, MD,Phd
role: STUDY_CHAIR
References:
citation: Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.