First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236975
• Other study ID #: PIONEER
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2016
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis

Intervention

Device:
• BuMA Supreme Biodegradable drug coating coronary stent system

• Resolute Integrity durable polymer stent system

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	CHU Chaleroi	Chaleroi
Belgium	Oost-limburg Hospital	Genk
Netherlands	AMC	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	Maasstad Hospital	Rotterdam
Portugal	Hospita; Garcia de Orta	Almada
Portugal	Santa Maria University Hospital	Lisboa
Portugal	Gaia/Espinho Hospital Centers	Oporto
Spain	University Hospital Madrid	Madrid
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Lumen Loss	The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.	Up to 9 month
Secondary	Angiographic endpoint	Acute Lumen Gain (mm);	9 and 12 month
Secondary	Angiographic endpoint	MLD (mm) post procedure and at 9 months;	9 and 12 month
Secondary	Angiographic endpoint	Diameter Stenosis (%) post procedure and at 9 months;	9 and 12 month
Secondary	Angiographic endpoint	Binary Restenosis (DS =50%) at 9 months	9 and 12 month
Secondary	Clinical endpoint	Acute success (device and procedural success)	9 and 12 month
Secondary	Cinical endpoint	Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 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).	9 and 12 month
Secondary	Clinical endpoint	Myocardial infarction (Q-wave, Non q-wave) at all time points.	9 and 12 month
Secondary	Clinical endpoint	Any revascularization at all time points.	9 and 12 month
Secondary	Clinical endpoint	Stent thrombosis according to the ARC definitions up to 12 months follow-up.	9 and 12 month