BIOFLOW III Asia Registry Orsiro Stent System

Coronary Artery Disease Clinical Trial

Official title:

Biotronik-Safety and Performance Registry for an All-comers Diabetic Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941290
• Other study ID #: G1206
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: September 26, 2017
• Start date: October 2013
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: BIOTRONIK Asia Pacific Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry. The sample subjects size may be increased in order to reach the subgroup sizes (Small Vessel and AMI).

Description:

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

An interesting group of analysis resulted to be diabetic patients. It has been concluded that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects after stenting as judged from comparison with historical control subjects. Results implicate accelerated restenosis as both a consequence of diabetes and a cause for increased mortality after PCI in diabetic patient.

Therefore this observational registry has been designed for the clinical evaluation of the Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES). Results will contribute to the collection of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in daily clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria

• Diabetes Mellitus:

• Known Diabetic on Pharmacological treatment.

• ACS NSTEMI with documented Hb A1c> 7%, even if not on Pharmacological treatment for diabetes.

• Patient has Symptomatic coronary artery disease

• Target lesion must be a de novo lesion located in a native coronary artery with reference vessel diameter =2.25 mm & =4.00 mm, lesion length =40 mm by visual estimate

• Patient should be receiving up to 3 stents and up to 2 stents per artery.

• Target lesion must be in a major coronary artery or branch with visually estimated stenosis =50% & <100% with TIMI flow=1.

• Subject provides signed informed consent for data release

• Subject is geographically stable and willing to comply with protocol required follow ups

• Subject is = 18 years of age

Exclusion Criteria:

• Pregnant and/or breast-feeding females who intend to become pregnant during the period of the registry

• Untreatable intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media

• Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained

• Currently participating in another study and primary endpoint is not reached yet

• If the subject has a high probability that a procedure other than predilatation, stent implantation and post dilatation will be required at time of index procedure for treatment of target vessel (e.g. atherectomy, cutting balloon or brachytherapy).

• Patients admitted for treatment of Diabetic ketoacidosis = 2 times in the past Six months (Brittle Diabetics).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus Type 1 or 2
• Diabetes Mellitus, Type 1
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
India	Fortis Hospitals Bannerghatta Road	Bangalore
India	Fortis Hospitals-Bannerghatta Road	Bangalore
India	GKNM Hospital	Coimbatore
India	Divine Heart and Multi-Specialty Hospital	Lucknow
India	King George Medical University	Lucknow
India	KMC Manjpal	Manial	Karnataka
India	Fortis Hospital	Mohali
India	Holy Family Hospital	Mumbai
India	BLK Super Speciality Hospital	New Delhi
India	Dharma Vira Heart Centre, Sir Ganga Ram Hospital	New Delhi
India	Fortis Escort Heart Institute	New Delhi
India	Ruby Hall Clinic	Pune
Malaysia	Institut Jantung Negara	Kuala Lumpur
Sri Lanka	Lanka Hospital	Colombo
Sri Lanka	National Hospital of Sri Lanka	Colombo
Sri Lanka	Sri Jaiewardenepura General Hospital	Colombo
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	Cho Ray Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
BIOTRONIK Asia Pacific Pte Ltd

Countries where clinical trial is conducted

China,  India,  Malaysia,  Sri Lanka,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)	12 months
Secondary	Target Lesion Failure (TLF)	Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)	6 months
Secondary	Clinically Driven Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6 and 12 months
Secondary	Clinically Driven Target Lesion Revascularization (TLR)	Any repeat revascularization of the target lestion.	6 and 12 months
Secondary	Stent Thrombosis rate using ARC definition	Definite, Probable and Possible Stent ThrombOsis	12 months
Secondary	Clinical device success	Successful delivery and deployment of the investigational stent(s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.	Participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	Clinical Procedure Success	Successful delivery and deployment of the investigational stent(s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.; In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success.; * Apart from post-dilatation with a non-compliant balloon	Participants will be followed for the duration of hospital stay, an expected average of 2 days