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Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID

NCT04403048 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2020-05-27

No results posted yet for this study

Summary

Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwise provisional stent strategy with main branch-only stenting followed by provisional balloon angioplasty with or without stenting of the side branch (SB). Stenting of the side branch is indicated when the angiographic result in SB is clearly suboptimal and when flow remains reduced. Upfront use of two stent techniques may be indicated in very complex lesions with large calcified side branches ( most likely to supply at least 10% of fractional myocardial mass), with a long ostial side branch lesion (\>5mm) or anticipated difficulty in accessing an important side branch after main branch stenting, and true distal LM bifurcations.

From a technical point of view, we propose a "Provisional DCB approach" that differs from the standard provisional approach with obligatory SB predilation and good lesion preparation. In case of an adequate result of predilation, the procedure on the SB ends with the DCB deployment. This is followed by main branch stenting with DES, finished with POT. Final 'kissing' balloon dilation is generally not recommended because there is no advantage from final kissing with the one-stent technique. With this approach, there is no need for re-wiring, re-ballooning, side branching and wire jailing and final kissing. This technique is close to a contemporary approach to bifurcation lesions based on the fundamental philosophy of the European Bifurcation Club (EBC): keep it simple, systematic, and safe, with a limited number of stents that should be well apposed and expanded with limited overlap, with respect of the original bifurcation anatomy.

Conditions

  • Stable Angina
  • Ischemic Heart Disease
  • Coronary Artery Disease
  • Unstable Angina
  • NSTEMI - Non-ST Segment Elevation MI

Interventions

PROCEDURE

Provisional DCB approach PCI procedure

Intervention is explained in detail in group description

PROCEDURE

Standard provisional approach PCI procedure

Intervention is explained in detail in group description

Sponsors & Collaborators

  • Clinical Hospital Center Rijeka

    lead OTHER

Principal Investigators

  • Deiti Prvulovic, MD, PhD · Clinical Hospital Center Rijeka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-04-30
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403048 on ClinicalTrials.gov