Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions. (Morph RCT-1)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioMime™ Morph - Sirolimus Eluting Coronary Stent System
Xience family Everolimus Coronary Stent Systems
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patient must be at least ≥18 years of age.
- Significant de novo native coronary artery stenosis as part of Ischemic Heart Disease with lesion length of ≥26 mm and ≤56 mm (irrespective of number of lesions) with reference vessel diameter of (Proximal to Distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.50 - 3.00 mm.
- Patient with lesion(s), with a visually estimated stenosis of ≥50% and <100% with a TIMI flow of ≥1.
- Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. This includes clinical trials of medication and invasive procedures, questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
- Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal.
- Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable Regulatory Authorities.
- Patient must agree to undergo all clinical investigations and follow up visits as per protocol.
Exclusion Criteria:
- Patients with known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, anti-platelet medication specified for use in the study, everolimus and sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure(Pregnancy should be confirmed based on positive urine pregnancy test as part of screening procedure)
- An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT.
- Patient has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Patient has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK-MB/Troponin T/Troponin I values have not returned to within normal limits at the time of procedure.
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
- Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
- Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease.
- Patient with active bleeding disorders.
- Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a White Blood Cell count of <3,000 cells/mm3 or documented or suspected liver disease (including laboratory evidence of Hepatitis B and C)
- Known renal insufficiency (e.g., estimated Glomerular Filtration rate <60 ml/kg/m² or Serum Creatinine level of > 2.0 mg/dL, or patient on dialysis).
- Patient has had a Cerebrovascular Accident (CVA) or Transient Ischemic Neurological Attack (TIA) within the past 6 months.
- Patient belonging to a vulnerable population (per Investigator's judgment, e.g., subordinate hospital staff or Sponsor staff).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BioMime™ Morph - Sirolimus Eluting Coronary Stent System
Xience family Everolimus Coronary Stent Systems
Arm Description
Outcomes
Primary Outcome Measures
Target Lesion Failure (TLF)
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization.
Secondary Outcome Measures
Target Lesion Failure
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization.
MACE
Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR).
Stent Thrombosis Rate (As per Academic Research Consortium)
Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Ischemia-driven Target Vessel Revascularization (ID-TVR)
Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Full Information
NCT ID
NCT03721614
First Posted
October 23, 2018
Last Updated
August 13, 2019
Sponsor
Meril Life Sciences Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03721614
Brief Title
Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.
Acronym
Morph RCT-1
Official Title
A Prospective, Active Control, Open-label, Multinational, Randomized Clinical Trial Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems to Evaluate Safety and Performance in Patients With Long de Novo Lesions.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meril Life Sciences Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures.
All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure.
10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BioMime™ Morph - Sirolimus Eluting Coronary Stent System
Arm Type
Experimental
Arm Title
Xience family Everolimus Coronary Stent Systems
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
BioMime™ Morph - Sirolimus Eluting Coronary Stent System
Intervention Description
Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
Intervention Type
Device
Intervention Name(s)
Xience family Everolimus Coronary Stent Systems
Intervention Description
Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization.
Time Frame
6 months (±14 days)
Secondary Outcome Measure Information:
Title
Target Lesion Failure
Description
Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization.
Time Frame
1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month)
Title
MACE
Description
Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR).
Time Frame
1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Title
Stent Thrombosis Rate (As per Academic Research Consortium)
Description
Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Time Frame
1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Title
Ischemia-driven Target Vessel Revascularization (ID-TVR)
Description
Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Other Pre-specified Outcome Measures:
Title
Clinical Success
Description
On a per patient basis, technical success without complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.
Time Frame
Within 48 hours after the index procedure or at hospital discharge, whichever is sooner
Title
User ratings on technical properties
Description
User's satisfaction Rating on a scale of 0 - 5 on the parameters of the coronary listed below:
a) Flexibility b) Pushability c) Trackability d) Crossability e) Inflation time f) Deflation time g) Ease of removal h) Radiopaque marker visibility (Where 0=very poor comfort, 1=poor comfort, 2=below average, 3=average, 4=good and 5=excellent).
Time Frame
Baseline]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be at least ≥18 years of age.
Significant de novo native coronary artery stenosis as part of Ischemic Heart Disease with lesion length of ≥26 mm and ≤56 mm (irrespective of number of lesions) with reference vessel diameter of (Proximal to Distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.50 - 3.00 mm.
Patient with lesion(s), with a visually estimated stenosis of ≥50% and <100% with a TIMI flow of ≥1.
Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. This includes clinical trials of medication and invasive procedures, questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal.
Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable Regulatory Authorities.
Patient must agree to undergo all clinical investigations and follow up visits as per protocol.
Exclusion Criteria:
Patients with known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, anti-platelet medication specified for use in the study, everolimus and sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure(Pregnancy should be confirmed based on positive urine pregnancy test as part of screening procedure)
An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT.
Patient has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
Patient has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK-MB/Troponin T/Troponin I values have not returned to within normal limits at the time of procedure.
Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease.
Patient with active bleeding disorders.
Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a White Blood Cell count of <3,000 cells/mm3 or documented or suspected liver disease (including laboratory evidence of Hepatitis B and C)
Known renal insufficiency (e.g., estimated Glomerular Filtration rate <60 ml/kg/m² or Serum Creatinine level of > 2.0 mg/dL, or patient on dialysis).
Patient has had a Cerebrovascular Accident (CVA) or Transient Ischemic Neurological Attack (TIA) within the past 6 months.
Patient belonging to a vulnerable population (per Investigator's judgment, e.g., subordinate hospital staff or Sponsor staff).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Ashok Thakkar, Ph.D
Phone
9879443584
Email
ashok.thakkar@merillife.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Kartik Vyas
Phone
9619129010
Email
kartik.vyas@merillife.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ertugrul Okuyan
Organizational Affiliation
Bagcilar Egitim ve Arastirma Hastanesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Omer Kozan
Organizational Affiliation
Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Jan - Peter V Kuijk
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Jakub Podolec
Organizational Affiliation
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Andrzej Ochala
Organizational Affiliation
Zaklad Kardiologii Inwazyjnej
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Oleg Polonetsky
Organizational Affiliation
National Scientific and Practical Centre - Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Orazbek Sakhov
Organizational Affiliation
City Heart Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.
We'll reach out to this number within 24 hrs