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The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Sponsor:
Information provided by (Responsible Party):
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier:
NCT01915420
First received: July 29, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery lesions in all-day clinical practice.


Condition
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Coronary Stenosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry

Resource links provided by NLM:


Further study details as provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:

Primary Outcome Measures:
  • Major Adverse Cardiac Event (MACE) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death


Secondary Outcome Measures:
  • Acute procedural success [ Time Frame: At the end of hospital stay (maximum of 7 days) ] [ Designated as safety issue: Yes ]
    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.

  • Acute device success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
    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.

  • Scaffold thrombosis [ Time Frame: At time of intervention, and at 6, 12, 24, and 36 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: At time of intervention, and at 6, 12,24, and 36 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: At time of intervention, and at 6, 12, 24, and 36 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death

  • Ischemia driven target vessel revascularisation (TVR) [ Time Frame: at 6, 12, 24, and 36 month ] [ Designated as safety issue: Yes ]
  • In-lesion % diameter stenosis [ Time Frame: Baseline and final at time of intervention and at 24 months FU ] [ Designated as safety issue: No ]
    QCA: Independent CoreLab

  • Minimal lumen diameter (MLD) [ Time Frame: Baseline and final at time of intervention and at 24 months FU ] [ Designated as safety issue: No ]
    QCA: Independent CoreLab

  • In-scaffold late lumen loss (LLL) [ Time Frame: At 24 months FU ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with complex coronary artery lesions

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915420

Contacts
Contact: Detlef G Mathey, Prof. Dr. +4940889009 ext 152 dgmathey@web.de

Locations
Germany
Medical Care Center Prof. Mathey, Prof. Schofer GmbH Recruiting
Hamburg, Germany, 22391
Contact: Detlef G Mathey, Prof. Dr.    +4940889009 ext 152    dgmathey@web.de   
Sub-Investigator: Joachim Schofer, Prof. Dr.         
Sub-Investigator: Carsten Schwencke, PD Dr.         
Sponsors and Collaborators
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Investigators
Principal Investigator: Detlef G Mathey, Prof. Dr. Medical Care Center Prof. Mathey, Prof. Schofer GmbH
  More Information

Publications:
Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier: NCT01915420     History of Changes
Other Study ID Numbers: ASSURE ROT
Study First Received: July 29, 2013
Last Updated: December 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:
Drug eluting stent
Bioabsorbable
Bioresorbable
Coronary Stent
Scaffold
Stents
Angioplasty
Coronary Artery Disease
Stentthrombosis
Rotational atherectomy

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Coronary Restenosis
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014