Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions

NCT04865588 | Completed Results FDA Device

• 1 other identifier: GCO 21-0532
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

calcified plaque; angioplasty; cutting balloon

Outcome Measures

Primary Outcomes (1)

• Minimum Stent Area After Percutaneous Coronary Intervention

  Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)

  Post-procedure, Day 0

Secondary Outcomes (30)

• In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation

  Post-procedure, Day 0

• Minimum Percent Stent Expansion After Percutaneous Coronary Intervention

  Post-procedure, Day 0

• Mean Percent Stent Expansion After Percutaneous Coronary Intervention

  Post-procedure, Day 0

• Number of Participants With Dissection After Percutaneous Coronary Intervention

  Post-procedure, Day 0

• Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention

  Post-Procedure, Day 0

Study Arms (2)

rotational atherectomy + cutting balloon

ACTIVE COMPARATOR

angioplasty with rotational atherectomy followed by cutting balloon

Procedure: rotational atherectomy; Device: cutting balloon

rotational atherectomy + plain old balloon

ACTIVE COMPARATOR

angioplasty with rotational atherectomy followed by plain old balloon

Procedure: rotational atherectomy; Device: plain old balloon

Interventions

rotational atherectomy PROCEDURE

angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification

rotational atherectomy + cutting balloon; rotational atherectomy + plain old balloon

cutting balloon DEVICE

a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs

rotational atherectomy + cutting balloon

plain old balloon DEVICE

current standard treatment of stent placement

rotational atherectomy + plain old balloon

Eligibility Criteria

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

You may qualify if:

• Adults Patients ≥18 years of age
• Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
• Patients eligible for percutaneous coronary intervention

You may not qualify if:

• Patients in cardiogenic shock
• Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
• Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
• Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, \< 2 years postmenopausal, or does not consistently use effective methods of contraception
• Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months
• Currently participating in another investigational drug or device study
• Patients referred to coronary artery bypass grafting after heart team discussion
• Lesion(s) with angulation \> 45 degrees by visual estimate
• Lesion(s) stenosis through which a guidewire will not pass.
• Last remaining vessel with compromised (\<30%) left ventricular function
• Saphenous vein grafts
• Angiographic evidence of thrombus
• Angiographic evidence of significant dissection at the treatment site
• Lesion(s) with previously placed stent within 10 mm (visual estimate)

Sponsors & Collaborators

• Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.: lead

Study Sites (2)

The Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Saint Francis Hospital and Heart Center

Roslyn, New York, 11576, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

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

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

Results Point of Contact

• Title: Director of The Zena and Michael A. Wiener Cardiovascular Institute
• Organization: Icahn School of Medicine at Mount Sinai

samin.sharma@mountsinai.org

(212) 241-4021

Study Officials

• Samin K Sharma, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine/Cardiology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 29, 2021
• Study Start: May 13, 2022
• Primary Completion: April 4, 2023
• Study Completion: December 12, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)