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

NCT01915420 | Unknown DMC

• 1 other identifier: ASSURE ROT
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Drug eluting stent; Bioabsorbable; Bioresorbable; Coronary Stent; Scaffold; Stents; Angioplasty; Coronary Artery Disease; Stentthrombosis; Rotational atherectomy

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Event (MACE)

  Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death

  at 24 months

Secondary Outcomes (10)

• Acute procedural success

  At the end of hospital stay (maximum of 7 days)

• Acute device success

  At time of intervention

• Scaffold thrombosis

  At time of intervention, and at 6, 12, 24, and 36 months

• Cardiac death

  At time of intervention, and at 6, 12,24, and 36 months

• Myocardial infarction

  At time of intervention, and at 6, 12, 24, and 36 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with complex coronary artery lesions

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.: lead

Study Sites (1)

Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Hamburg, Hamburg, 22391, Germany

RECRUITING

Related Publications (4)

• Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.

  PMID: 21958884 BACKGROUND

• Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.

  PMID: 21959320 BACKGROUND

• Basavarajaiah S, Naganuma T, Latib A, Colombo A. Can bioabsorbable scaffolds be used in calcified lesions? Catheter Cardiovasc Interv. 2014 Jul 1;84(1):48-52. doi: 10.1002/ccd.24939. Epub 2013 Aug 31.

  PMID: 23592566 BACKGROUND

• Patel N, Banning AP. Bioabsorbable scaffolds for the treatment of obstructive coronary artery disease: the next revolution in coronary intervention? Heart. 2013 Sep;99(17):1236-43. doi: 10.1136/heartjnl-2012-303346. Epub 2013 Mar 8.

  PMID: 23474621 BACKGROUND

MeSH Terms

Conditions

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

Study Officials

• Detlef G Mathey, Prof. Dr.

  Medical Care Center Prof. Mathey, Prof. Schofer GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Detlef G Mathey, Prof. Dr.

CONTACT

+4940889009; dgmathey@web.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2017
• Last Updated: February 6, 2015

Record last verified: 2015-02

Locations

DE (1)