NCT04865588Completed
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Source: ClinicalTrials.gov · Last updated 22 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 14 Apr 2021
- Start date
- 13 May 2022
- Primary completion date
- 4 Apr 2023
- Lead sponsor
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
- Diseases
- Coronary artery disease
- NCT number
- NCT04865588
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 13 May 2022 to the primary completion date, 4 Apr 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in another investigational drug or device study
- Lesion(s) with previously placed stent within 10 mm (visual estimate)
Other illness
- 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
- 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
- Patients referred to coronary artery bypass grafting after heart team discussion
- Angiographic Specific Exclusion Criteria:
Age
- 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
Other
- Patients in cardiogenic shock
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Saint Francis Hospital and Heart Center Coordinator of this site? Confirm its status | Roslyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.