PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

NCT04014595 | Unknown DMC

• 1 other identifier: SK 110 -- 168/11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

Conditions

Coronary Artery Disease

Keywords

Calcified coronary lesions

Outcome Measures

Primary Outcomes (2)

• Primary endpoint: Numerical in-stent acute lumen gain in mm

  The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.

  At the end of the index procedure

• Co-primary OCT endpoint: Ratio of stent expansion index (SEI)

  The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure

  At the end of the index procedure

Secondary Outcomes (10)

• Numerical in-stent late lumen loss at 9 month follow-up angiography in mm

  9 months follow-up

• Rate of angiographic success in percent

  Peri-procedural

• Rate of strategy success in percent

  Peri-procedural

• Rate of target vessel failure in percent

  9 months, 1 and 2 years follow-up

• Rate of in-segment binary restenosis at 9 months in percent

  9 months follow-up

Other Outcomes (1)

• Ratio of OCT-measured stent excentricity index

  Intra-procedural

Study Arms (1)

Rotational atherectomy + Cutting Balloon

Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions

Procedure: Rotational atherectomy in combination with cutting balloon

Interventions

Rotational atherectomy in combination with cutting balloon PROCEDURE

Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.

Rotational atherectomy + Cutting Balloon

Eligibility Criteria

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

Study Population

Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Age above 18 years and consentable
• Angiographically proven coronary artery disease
• Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
• Written informed consent
• De-novo lesion in a native coronary artery
• Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
• Luminal diameter reduction of 50-100% by visual estimation
• Severe calcification of the target lesion (for definition see appendix)

You may not qualify if:

• Myocardial infarction (within 1 week)
• Decompensated heart failure
• Limited long term prognosis due to other conditions
• Target lesion is in a coronary artery bypass graft
• Target lesion is an in-stent restenosis
• Target vessel thrombus

Sponsors & Collaborators

• Segeberger Kliniken GmbH: lead

Study Sites (1)

Herzzentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

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

Study Officials

• Gert Richardt, Prof.

  Herzzentrum Segeberger Kliniken GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 10, 2019
• Study Start: January 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: July 31, 2025
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

DE (1)