Clinical Trial on Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Coronary Artery Disease, Coronary Disease - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Detailed Description

Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.

Study Type

Observational

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Hamburg, Germany, 22391
    - Recruiting
    - Medical Care Center Prof. Mathey, Prof. Schofer GmbH
    - Contact:
      
      Detlef G Mathey, Prof. Dr.
      
      Phone Number: 152 +4940889009
      
      Email: dgmathey@web.de
    - Sub-Investigator:
      
      Joachim Schofer, Prof. Dr.
    - Sub-Investigator:
      
      Carsten Schwencke, PD Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with complex coronary artery lesions

Description

The recommendation to implant BVS in an individual patient in whom rotational atherectomy of a complex target lesion has been conducted, is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated:

Eligible:

Regarding to patient

Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, NSTEMI and unstable angina) due to one or more complex de novo native coronary artery lesions
Patients with evidence of myocardial ischemia

Regarding to lesion

Reference vessel diameter ≥ 2.5 mm and ≤ 3.8 mm, visually estimated or by online QCA
Percent diameter stenosis ≥ 50% and < 100%, visually estimated or by online QCA
TIMI ≥1
Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion
Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure

Not eligible:

Regarding to patient

Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated
Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated
Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
Patient is currently experiencing clinical symptoms consistent with STEMI
Patient has current unstable arrhythmias
Patient has a known left ventricular ejection fraction < 30%
Patient has received a heart transplant or any other organ transplant or is waiting for any organ transplant
Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after procedure
Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease
Patient is receiving or scheduled to receive chronic anticoagulation therapy
Elective surgery is planned within the first 6 month after the procedure that will require discontinuing either aspirin or clopidogrel
Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of
< 3000 cells/mm3, or documented or suspected liver disease
Patient has known renal insufficiency
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has cerebrovascular accident or transient ischemic neurological attack within the past six month
Patient has had a significant GI or urinary bleed within the past six months
Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause noncompliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., les than one year)
Women of childbearing potential who have not undergone surgical sterilization or are not post- menopausal

Regarding to lesion

Target lesion(s) meets none of the following criteria:

Aorto-ostial location
Left main location
Located within 2 mm of the origin of LAD or LCX
Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
Ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
Excessive tortuosity proximal to or within the lesion (extreme angulation proximal to or within the lesion)
Restenotic from previous intervention

Target vessel is not containing thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Event (MACE) Time Frame: at 24 months	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death	at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success Time Frame: At the end of hospital stay (maximum of 7 days)	Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.	At the end of hospital stay (maximum of 7 days)
Acute device success Time Frame: At time of intervention	Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.	At time of intervention
Scaffold thrombosis Time Frame: At time of intervention, and at 6, 12, 24, and 36 months		At time of intervention, and at 6, 12, 24, and 36 months
Cardiac death Time Frame: At time of intervention, and at 6, 12,24, and 36 months		At time of intervention, and at 6, 12,24, and 36 months
Myocardial infarction Time Frame: At time of intervention, and at 6, 12, 24, and 36 months		At time of intervention, and at 6, 12, 24, and 36 months
Ischemia driven target lesion revascularisation (TLR) Time Frame: At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 24, and 36 months	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death	At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 24, and 36 months
Ischemia driven target vessel revascularisation (TVR) Time Frame: at 6, 12, 24, and 36 month		at 6, 12, 24, and 36 month
In-lesion % diameter stenosis Time Frame: Baseline and final at time of intervention and at 24 months FU	QCA: Independent CoreLab	Baseline and final at time of intervention and at 24 months FU
Minimal lumen diameter (MLD) Time Frame: Baseline and final at time of intervention and at 24 months FU	QCA: Independent CoreLab	Baseline and final at time of intervention and at 24 months FU
In-scaffold late lumen loss (LLL) Time Frame: At 24 months FU		At 24 months FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Investigators

Principal Investigator: Detlef G Mathey, Prof. Dr., Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria