Clinical trial NCT03721614: 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.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Meril Life Sciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
Primary purpose: TREATMENT

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. \[Time Frame: Post-procedure and 6 months (±14 days)\]


Eligibility criteria: Inclusion Criteria:

1. Patient must be at least ≥18 years of age.
2. 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.
3. Patient with lesion(s), with a visually estimated stenosis of ≥50% and \<100% with a TIMI flow of ≥1.
4. 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.
5. Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal.
6. 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.
7. Patient must agree to undergo all clinical investigations and follow up visits as per protocol.

Exclusion Criteria:

1. 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.
2. 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)
3. An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT.
4. 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).
5. 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.
6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
7. Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
8. Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease.
9. Patient with active bleeding disorders.
10. 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)
11. 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).
12. Patient has had a Cerebrovascular Accident (CVA) or Transient Ischemic Neurological Attack (TIA) within the past 6 months.
13. Patient belonging to a vulnerable population (per Investigator's judgment, e.g., subordinate hospital staff or Sponsor staff).

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 6 months (±14 days)
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month)
measure: MACE
timeFrame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
measure: Stent Thrombosis Rate (As per Academic Research Consortium)
timeFrame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
measure: Ischemia-driven Target Vessel Revascularization (ID-TVR)
timeFrame: 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month)
Other outcomes:
measure: Clinical Success
timeFrame: Within 48 hours after the index procedure or at hospital discharge, whichever is sooner
measure: User ratings on technical properties
timeFrame: Baseline]
Locations:
Study officials:
affiliation: Bagcilar Egitim ve Arastirma Hastanesi
name: Dr. Ertugrul Okuyan
role: PRINCIPAL_INVESTIGATOR
affiliation: Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi
name: Dr. Omer Kozan
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Dr. Jan - Peter V Kuijk
role: PRINCIPAL_INVESTIGATOR
affiliation: Krakowski Szpital Specjalistyczny im. Jana Pawla II
name: Dr. Jakub Podolec
role: PRINCIPAL_INVESTIGATOR
affiliation: Zaklad Kardiologii Inwazyjnej
name: Dr. Andrzej Ochala
role: PRINCIPAL_INVESTIGATOR
affiliation: National Scientific and Practical Centre - Cardiology
name: Dr. Oleg Polonetsky
role: PRINCIPAL_INVESTIGATOR
affiliation: City Heart Center
name: Dr. Orazbek Sakhov
role: PRINCIPAL_INVESTIGATOR
References: