Skip to content

Percutaneous versus incisional approach for endovascular repair of aortic disease: a single-blind, single-center, randomized controlled trial

Percutaneous versus incisional approach for endovascular repair of aortic disease: a single-blind, single-center, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053161
Enrollment
Unknown
Registered
2021-11-13
Start date
2021-11-20
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic diseases

Interventions

EVAR percutaneous puncture group:The common femoral artery was punctured under ultrasound guidance, and the ProGlide stapler was preset, and then the corresponding vascular sheath was gradually expand
EVAR surgical incision group:Take a longitudinal incision at the midpoint of the groin, expose the common femoral artery, and perform puncture under direct vision
TEVAR percutaneous puncture group:The common femoral artery was punctured under ultrasound guidance, and the ProGlide stapler was preset, and then the skin was expanded and the corresponding vascular
TEVAR surgical incision group:Take a longitudinal incision at the midpoint of the groin, expose the common femoral artery, and perform puncture under direct vision

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with aortic disease (including aortic aneurysm, aortic dissection, aortic intramural hematoma, aortic perforating ulcer, etc.) who are planning to undergo aortic endovascular repair.

Exclusion criteria

Exclusion criteria: 1. Patients requiring emergency surgery; 2. Patients who refuse to participate in the trial; 3. After multidisciplinary discussion and radiologist's report, the peripheral calcification of the femoral artery access site was greater than 50%.

Design outcomes

Primary

MeasureTime frame
2 weeks postoperative quality of life score;1 month postoperative quality of life score;Access site complications;Access site infection;Postoperative bleeding/hematoma;Femoral artery occlusion;Access related arterial injury;Pseudoaneurysm;Perioperative mortality;

Secondary

MeasureTime frame
Duration of ICU;Return to work/life time;Duration of postoperative pain;

Countries

China

Contacts

Public ContactZhao Jichun
zhaojc3@163.com+86 18980606212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026