ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)

NCT04742478 | Recruiting

• 1 other identifier: 2020/2932
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 2

Brief Summary

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

Conditions

Coronary Artery Calcification

Keywords

Atherosclerotic Calcification; Medial Artery Calcification; Rotational Atherectomy

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint (Procedural success)

  Procedural success defined as \< 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow.

  Duration of procedure

Secondary Outcomes (5)

• Death

  1 year

• Periprocedural myocardial infarction (MI)

  within 48 hours of procedure

• Complications

  within 48 hours of procedure

• Complication

  within 48 hours of procedure

• Procedural time

  Duration of procedure

Study Arms (2)

Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study)

Informed consent to be obtained either prior to PCI with rotational atherectomy planned or within 48 hours after rotational atherectomy. There will be data collection of history/demographics, laboratory results, symptoms, any serious adverse events recording for this cohort as well as a telephone follow up at 12months post rotational atherectomy.

Procedure: Rotational Atherectomy

Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)

Subjects that were demised or refused to give consent will fall under this cohort. The data collection of this cohort will be done through screening of in-hospital data via available local PCI database/registry.

Procedure: Rotational Atherectomy

Interventions

Rotational Atherectomy PROCEDURE

Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.

Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study); Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with signed informed consent for percutaneous coronary intervention (PCI) and are eligible for calcium debulking treatment with rotational atherectomy with or without other forms of calcium debulking therapies will be enrolled into this study.

You may qualify if:

• Able to understand and sign an informed consent form
• Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement
• Subjects willing to comply with all research and follow-up requirements.
• Angiographic criteria (ONE of the following criteria MUST be met)
• Target lesions visually have at least moderate calcifications\*
• Target lesion balloon dilatation failure
• Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.
• Procedural criteria
• All patients treated with RA with or without other forms of debulking therapy
• Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.

You may not qualify if:

• Decline to give consent

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Kokura Memorial hospital

Kitakyushu, 802-8555, Japan

RECRUITING

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Related Publications (2)

• Lee MS, Park KW, Shlofmitz E, Shlofmitz RA. Comparison of Rotational Atherectomy Versus Orbital Atherectomy for the Treatment of Heavily Calcified Coronary Plaques. Am J Cardiol. 2017 May 1;119(9):1320-1323. doi: 10.1016/j.amjcard.2017.01.025. Epub 2017 Feb 10.

  PMID: 28258729 BACKGROUND

• Sharma SK, Tomey MI, Teirstein PS, Kini AS, Reitman AB, Lee AC, Genereux P, Chambers JW, Grines CL, Himmelstein SI, Thompson CA, Meredith IT, Bhave A, Moses JW. North American Expert Review of Rotational Atherectomy. Circ Cardiovasc Interv. 2019 May;12(5):e007448. doi: 10.1161/CIRCINTERVENTIONS.118.007448.

  PMID: 31084239 BACKGROUND

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Khung Keong Yeo

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

• Shoichi Kuramitsu

  Kokura Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Low

CONTACT

67042280; james.low.j.y@nhcs.com.sg

Phoebe Chin

CONTACT

67042268; chin.ting.ting@nhcs.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: March 10, 2021
• Primary Completion: February 29, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); SG (1)