Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population

Cardiac Disease Clinical Trial

Official title:

Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in High Bleeding Risk PCI Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500912
• Other study ID #: NL73419.100.20
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Research Maatschap Cardiologen Rotterdam Zuid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).

Description:

Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents Study population: 2 x 368 (736) patients, who undergo a PCI and are at high risk for bleeding (HBR). Intervention: Patients are treated according to the randomized regimen at index PCI and at planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent DAPT treatment (combination and duration) is according to the Guidelines of the European Society of Cardiology for Myocardial Revascularization. Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure. Primary study parameters/outcome of the study: The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 736
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patients are eligible for inclusion into the study if the following criteria are met.

• Patients of 18 years and above
• Written or witnessed oral consent to participate in the study
• Native coronary artery lesions eligible for PCI with stents with no restrictions in number of lesions and stents, vessel size or lesion complexity, apart from stent thrombosis.
• Patients at high risk for bleeding according to the HBR ARC criteria: Patients meet the HBR ARC criteria if =1 major or =2 minor criteria are met.

Major HBR criteria are the following:

• Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at least 12 months
• Severe or end-stage chronic kidney failure (GFR = 30 ml/min)
• Hemoglobin (Hb) level at screening < 11g/dl or < 6.8 mmol/l
• Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent
• Moderate or severe baseline true thrombocytopenia (platelet count <100 *10^9/L)
• History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K deficiency, Factor V or VII deficiency etc.
• Liver cirrhosis with portal hypertension
• Active malignancy (other than skin) within the past 12 months
• Spontaneous intracranial haemorrhage ICH (at any time)
• Traumatic intracranial haemorrhage ICH within 12 months
• Presence of a brain arterio-venous malformation (AVM)
• Moderate or severe ischemic stroke within the past 6 months
• Nondeferrable major surgery on DAPT after PCI
• Recent major surgery or major trauma within 30 d before PCI

Minor HBR criteria are the following:

• Age = 75 years
• Moderate chronic kidney disease (GFR >30 and <60 ml/min)
• Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL / 6.8-7.4 mmol/l for women
• Any ischemic stroke at any time not meeting the major criterion
• Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months
• Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs Exclusion criteria:

Patients are not eligible if any of the following applies:

• Treated with stents other than Supraflex Cruz or Ultimaster within 6 months prior to index procedure
• Treatment of lesions with stent thrombosis
• Treatment of venous or arterial coronary grafts
• Treated for stent thrombosis in 12 months prior to index PCI procedure
• Treated with a bioresorbable scaffold 3 years before index PCI procedure
• Cardiogenic shock at index procedure
• Active SARS-CoV-2 infection or suspicion of SARS-CoV-2 infection
• Cannot provide written informed consent
• Under judicial protection, tutorship or curatorship
• Unable to understand and follow study-related instructions or unable to comply with study protocol
• Active bleeding requiring medical attention (BARC=2) at index PCI
• Life expectancy less than one year
• Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
• Any anticipated PCI after index PCI, unless planned and scheduled at index PCI
• Participation in another stent or drug trial

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Hemorrhage
• High Bleeding Risk
• PCI

Intervention

Device:
• Supraflex Cruz 60 Micron
percutaneous coronary intervention
• Ultimaster Tansei 80 Micron
percutaneous coronary intervention

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch ziekenhuis	's-Hertogenbosch
Netherlands	Meander ziekenhuis	Amersfoort
Netherlands	Rijnstate ziekenhuis	Arnhem
Netherlands	Tergooi ziekenhuis Blaricum	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht
Netherlands	Catherina ziekenhuis	Eindhoven
Netherlands	MCL Leeuwarden	Leeuwarden
Netherlands	St.Antonius ziekenhuis	Nieuwegein
Netherlands	Maasstadziekenhuis	Rotterdam
Netherlands	Ziekenhuis Zorgsaam	Terneuzen

Sponsors (2)

Lead Sponsor	Collaborator
Pieter C.Smits	Sahajanand Medical Technologies Limited

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net Adverse Clinical Endpoints (NACE)	The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.	1 year
Secondary	Major adverse cardiac and cerebral events (MACCE)	Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke	1 year
Secondary	Major or clinically relevant non-major bleeding (MCB)	Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events	1 year
Secondary	Target Lesion Failure (TLF)	Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization	1 year
Secondary	Target vessel failure (TVF)	Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization	1 year
Secondary	The composite of cardiovascular death, myocardial infarction and stroke	The composite endpoint of cardiovascular death, myocardial infarction and stroke	1 year
Secondary	The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5	The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5	1 year
Secondary	Stent thrombosis	Stent thrombosis according to the ARC definitions	1 year
Secondary	Myocardial infarction	Myocardial infarction.	1 year
Secondary	Urgent target vessel revascularization	Urgent target vessel revascularization.	1 year
Secondary	Non-target vessel revascularization	Non-target vessel revascularization.	1 year
Secondary	Clinically indicated target vessel revascularization	Clinically indicated target vessel revascularization.	1 year
Secondary	Bleeding events	Bleeding events according to the BARC, TIMI and GUSTO classification	1 year
Secondary	Transfusion rates	Transfusion rates both in patients with and/or without clinically detected over bleeding	1 year
Secondary	Event rates according to the PRECISE-DAPT	Event rates according to the PRECISE-DAPT score	1 year
Secondary	Procedural success	Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)	At completion of the baseline PCI
Secondary	Device success	Device success (applying a lesion-level analysis)	At discharge of baseline hospitalisation, on average 3 days